ClinicalTrials.gg
CompletedNCT06403605Updated Nov 10, 2025Results posted

Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

An interventional study of Mirragen Advanced Wound Matrix and Fibracol in Diabetic Foot Ulcer, Ulcer Foot and Diabetic Foot, sponsored by ETS Wound Care, LLC. Completed at 15 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-10.

Sponsored by ETS Wound Care, LLC · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Sep 2022, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available treatments for diabetic foot wounds.

Read the detailed description

This study is a prospective, multi-center, RCT designed to collect patient outcome data on two commercially available treatments for DFUs. The trial will be single blinded in regard to wound healing assessment (another clinician, other than the investigator at each site will assess wound healing) and confirmation of wound healing will be overseen by an independent adjudication committee made up of wound care experts. The study will last twelve weeks, with a two week screening period prior to enrollment.

There are two arms in the study:

Arm 1: SOC therapy (offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement)) and wound care covering with resorbable bioactive glass fiber, MIRRAGEN™ Advanced Wound Matrix, followed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).

ARM 2: SOC therapy (offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement)) and wound care covering with calcium alginate Fibracol dressing follwed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).

02

Conditions studied

  • Diabetic Foot Ulcer
  • Ulcer Foot
  • Diabetic Foot

Keywords

  • DFU
  • Ulcer
03

In context

Diabetic Foot

1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's enrollment of 148 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

ETS Wound Care, LLC is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subjects must be at least 18 years of age or older.
  2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
  3. At randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with a photographic planimetry app.
  4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
  5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
  6. The target ulcer must be full thickness on the foot or ankle that does not probe to bone.
  7. Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:

    1. TCOM ≥30 mmHg
    2. ABI between 0.7 and 1.3
    3. PVR: Biphasic
    4. TBI ˃0.6
    5. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle
  8. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
  9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to randomization.
  10. The subject must consent to using the prescribed off-loading method for the duration of the study.
  11. The subject must agree to attend the weekly study visits required by the protocol.
  12. The subject must be willing and able to participate in the process.

Exclusion criteria

Exclusion Criteria:

  1. A subject known to have a of \< 6 months is excluded.
  2. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
  3. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
  4. A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
  5. A subject receiving (including systemic at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
  6. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
  7. A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
  8. If a subject has a (HbA1c) greater than or equal to 12% taken at or within 3 months of the initial screening visit he/she is excluded.
  9. If a subject has a serum creatinine ≥ 3.0mg/dL within 6 months of randomization he/she is excluded.
  10. The subject is excluded if the surface area measurement of the target ulcer has reduced in size by more than 30% in the 2 weeks prior to the initial screening during the 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV1/randomization visit during which time the subject received SOC.
  11. A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
  12. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
  13. A potential subject with end stage renal disease requiring dialysis is excluded.
  14. A subject who participated in a clinical trial involving treatment with an product within the previous 30 days is excluded.
  15. A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
  16. A subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
148 participants (actual)

Study arms

  • Experimental
    SOC primary dressing with MIRRAGEN™

    Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.

    Device: Mirragen Advanced Wound Matrix

  • Active comparator
    SOC primary dressing with FIBRACOL™

    A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.

    Device: Fibracol

Interventions

  • DeviceMirragen Advanced Wound Matrix

    Offloading - patient will be offloaded in a diabetic CAM boot after treatment, or total contact cast if patient cannot be fit in a diabetic boot. Other names; pressure relief. Additional "outer" dressing application - application of outer moisture retentive dressing, and a multilayer compression dressing. Other names; outer protective dressing. Mirragen Advanced Wound Matrix - application of Mirragen to wound site along with standard of care treatment.

  • DeviceFibracol

    Offloading - patient will be offloaded in a diabetic CAM boot after treatment, or total contact cast if patient cannot be fit in a diabetic boot. Other names; pressure relief. Additional "outer" dressing application - application of outer moisture retentive dressing, and a multilayer compression dressing. Other names; outer protective dressing. Fibracol - application of Fibracol to wound site along with standard of care treatment.

06

What researchers measure

Primary outcomes

  1. Complete Wound Healing

    The proportion of subjects achieving complete wound closure.

    Time frame: 12 weeks

Secondary outcomes

  1. Percentage Area Reduction (PAR)

    Percentage wound area reduction measured weekly with digital photographic planimetry and physical examination

    Time frame: 12 weeks

  2. Time to Heal

    The time to achieve complete wound closure within 12 weeks.

    Time frame: 12 weeks

  3. Changes in Quality of Life

    The WOUND-Q is a questionnaire measuring outcomes important to patients with chronic wounds. Five of the tool's 13 independently functioning scales (with 5 to 11 items each) were measured in this study. 'Assessment' measures how concerned someone has been with their wound(s). 'Drainage' measures how bothered someone has been by drainage from their wound(s). 'Smell' measures how bothered someone has been by the smell from their wound(s). 'Social' measures the impact of a person's wound(s) on their social life. 'Dressing' measures someone's satisfaction with their wound dressing. For all of these scales, possible responses to each item range from minimum 0 ('not at all') to maximum 4 ('very much'). To score a scale, the raw scores for the set of items in a scale are added together to produce a total raw score. The total raw score for the scale is then converted to a score that ranges from 0 to 100. For all, higher scores represent better outcomes.

    Time frame: 12 weeks

  4. Change in Pain Level

    The FACES pain scale was administered to the clinical trial participants at each visit. The trial participant selected their pain level with a series of faces that correspond to a number between 0 which implies no pain, up to 10 which implies the most severe pain.

    Time frame: 12 weeks

07

Results

Posted Nov 10, 2025

Participant flow

Randomization and Initial Treatment
Participant flow — Randomization and Initial Treatment
MilestoneSOC primary dressing with MIRRAGEN™SOC primary dressing with FIBRACOL™
Started7771
Completed7771
Not completed00
Follow-up
Participant flow — Follow-up
MilestoneSOC primary dressing with MIRRAGEN™SOC primary dressing with FIBRACOL™
Started7771
Completed5243
Not completed2528
Withdrew: Withdrawn per protocol with par <50% at week 61719
Withdrew: Adverse event42
Withdrew: Withdrawal by subject23
Withdrew: Lost to follow-up10
Withdrew: Death10
Withdrew: Other reasons04

Outcome measures

SecondaryPercentage Area Reduction (PAR)

Percentage wound area reduction measured weekly with digital photographic planimetry and physical examination

Time frame:
12 weeks
Reported as:
Mean · percent
Percentage Area Reduction (PAR)
percentSOC primary dressing with MIRRAGEN™SOC primary dressing with FIBRACOL™
mITT48.8 ± 82.8153.7 ± 65.78
PP93.7 ± 15.2889.7 ± 25.19
Statistical analysis
  • SOC primary dressing with MIRRAGEN™ vs SOC primary dressing with FIBRACOL™ · Mixed Models Analysis · p = 0.78 (Adjusted p value in the mITT analysis population.)
  • SOC primary dressing with MIRRAGEN™ vs SOC primary dressing with FIBRACOL™ · Mixed Models Analysis · p = 0.48 (Adjusted p value in the PP analysis population.)
SecondaryTime to Heal

The time to achieve complete wound closure within 12 weeks.

Time frame:
12 weeks
Reported as:
Mean · days
Time to Heal
daysSOC primary dressing with MIRRAGEN™SOC primary dressing with FIBRACOL™
mITT63.4 (56.6 to 70.1)72.5 (67.3 to 77.7)
PP57.5 (49.3 to 65.7)67.8 (60.5 to 75.2)
Statistical analysis
  • SOC primary dressing with MIRRAGEN™ vs SOC primary dressing with FIBRACOL™ · Log Rank · p = 0.049 (Adjusted p-value in the mITT population.)
  • SOC primary dressing with MIRRAGEN™ vs SOC primary dressing with FIBRACOL™ · Log Rank · p = 0.084 (Adjusted p value in the PP population.)
SecondaryChanges in Quality of Life

The WOUND-Q is a questionnaire measuring outcomes important to patients with chronic wounds. Five of the tool's 13 independently functioning scales (with 5 to 11 items each) were measured in this study. 'Assessment' measures how concerned someone has been with their wound(s). 'Drainage' measures how bothered someone has been by drainage from their wound(s). 'Smell' measures how bothered someone has been by the smell from their wound(s). 'Social' measures the impact of a person's wound(s) on their social life. 'Dressing' measures someone's satisfaction with their wound dressing. For all of these scales, possible responses to each item range from minimum 0 ('not at all') to maximum 4 ('very much'). To score a scale, the raw scores for the set of items in a scale are added together to produce a total raw score. The total raw score for the scale is then converted to a score that ranges from 0 to 100. For all, higher scores represent better outcomes.

Time frame:
12 weeks
Reported as:
Mean · units on a scale
Changes in Quality of Life
units on a scaleSOC primary dressing with MIRRAGEN™SOC primary dressing with FIBRACOL™
Assessment (mITT)18.3 ± 20.6817.0 ± 21.36
Drainage (mITT)16.6 ± 22.7711.8 ± 20.83
Smell (mITT)4.5 ± 23.061.4 ± 18.42
Social (mITT)11.6 ± 28.1415.2 ± 26.27
Dressing (mITT)9.0 ± 21.087.1 ± 18.04
Assessment (PP)28.1 ± 17.8924.6 ± 21.34
Drainage (PP)25.3 ± 19.5817.6 ± 18.57
Smell (PP)8.1 ± 20.733.4 ± 17.59
Social (PP)17.4 ± 29.3919.0 ± 25.53
Dressing (PP)14.2 ± 20.857.7 ± 18.55
SecondaryChange in Pain Level

The FACES pain scale was administered to the clinical trial participants at each visit. The trial participant selected their pain level with a series of faces that correspond to a number between 0 which implies no pain, up to 10 which implies the most severe pain.

Time frame:
12 weeks
Reported as:
Mean · score change [EOS - baseline]
Change in Pain Level
score change [EOS - baseline]SOC primary dressing with MIRRAGEN™SOC primary dressing with FIBRACOL™
mITT0.5 ± 2.470.8 ± 2.27
PP0.9 ± 2.241.0 ± 2.44
PrimaryComplete Wound Healing

The proportion of subjects achieving complete wound closure.

Time frame:
12 weeks
Reported as:
Count of participants · Participants
Complete Wound Healing
ParticipantsSOC primary dressing with MIRRAGEN™SOC primary dressing with FIBRACOL™
mITT3216
PP3216
Statistical analysis
  • SOC primary dressing with MIRRAGEN™ vs SOC primary dressing with FIBRACOL™ · Fisher Exact · p = 0.007

Adverse events

Collected over From enrollment until end of follow-up (up to 12 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SOC primary dressing with MIRRAGEN™1/67 (1.5%)6/67 (9%)5/67 (7.5%)
SOC primary dressing with FIBRACOL™0/66 (0%)3/66 (4.5%)5/66 (7.6%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
EventSOC primary dressing with MIRRAGEN™SOC primary dressing with FIBRACOL™
Cellulitis, right legInfections and infestations0/671/66
AnasarcaCardiac disorders0/671/66
Bilateral pleural effusionsRespiratory, thoracic and mediastinal disorders0/671/66
Acute respiratory failureRespiratory, thoracic and mediastinal disorders0/671/66
CystitisRenal and urinary disorders1/670/66
Deep space infection of left plantar mid footInfections and infestations1/670/66
Osteomyelitis of sacrumInfections and infestations1/670/66
Postoperative infection of non-study woundInfections and infestations1/670/66
Necrotizing fasciitisInfections and infestations1/670/66
Non-study diabetic foot wound infection with osteomyelitisInfections and infestations1/670/66
Most frequent other events
Most frequent other events
EventSOC primary dressing with MIRRAGEN™SOC primary dressing with FIBRACOL™
Index wound infectionInfections and infestations5/675/66

Baseline characteristics

Both modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.

Age, Continuous
Age, Continuous(years)SOC Primary Dressing With MIRRAGEN™SOC Primary Dressing With FIBRACOL™Total
mITT60.1 ± 16.8159.1 ± 14.2659.6 ± 15.50
PP60.2 ± 16.3457.7 ± 15.6059.1 ± 15.95
Sex: Female, Male
Sex: Female, Male(Participants)SOC Primary Dressing With MIRRAGEN™SOC Primary Dressing With FIBRACOL™Total
mITT — Female201838
mITT — Male474895
PP — Female11920
PP — Male332962
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SOC Primary Dressing With MIRRAGEN™SOC Primary Dressing With FIBRACOL™Total
mITT — American Indian or Alaska Native000
mITT — Asian101
mITT — Native Hawaiian or Other Pacific Islander000
mITT — Black or African American7411
mITT — White5760117
mITT — More than one race000
mITT — Unknown or Not Reported224
PP — American Indian or Alaska Native000
PP — Asian101
PP — Native Hawaiian or Other Pacific Islander000
PP — Black or African American527
PP — White373471
PP — More than one race000
PP — Unknown or Not Reported123
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SOC Primary Dressing With MIRRAGEN™SOC Primary Dressing With FIBRACOL™Total
mITT — Hispanic or Latino191433
mITT — Not Hispanic or Latino4852100
mITT — Unknown or Not Reported000
PP — Hispanic or Latino10919
PP — Not Hispanic or Latino342963
PP — Unknown or Not Reported000
BMI
BMI(kg/m²)SOC Primary Dressing With MIRRAGEN™SOC Primary Dressing With FIBRACOL™Total
mITT33.9 ± 8.4535.0 ± 8.9834.5 ± 8.71
PP34.3 ± 9.0636.4 ± 9.9935.3 ± 9.50
Tobacco use
Tobacco use(Participants)SOC Primary Dressing With MIRRAGEN™SOC Primary Dressing With FIBRACOL™Total
mITT — Current13821
mITT — Former202242
mITT — Never used tobacco343670
PP — Current8412
PP — Former131528
PP — Never used tobacco231942
Diabetes duration
Diabetes duration(years)SOC Primary Dressing With MIRRAGEN™SOC Primary Dressing With FIBRACOL™Total
mITT17.1 ± 13.5915.9 ± 9.5816.5 ± 11.71
PP15.7 ± 9.7516.4 ± 14.1816.0 ± 11.93
Age when first DFU appeared
Age when first DFU appeared(years)SOC Primary Dressing With MIRRAGEN™SOC Primary Dressing With FIBRACOL™Total
mITT58.2 ± 11.5653.6 ± 11.6055.9 ± 11.76
PP58.9 ± 11.8654.4 ± 11.0956.8 ± 11.66

26 further baseline measures are reported on the registry.

08

Study locations

15 sites
  • LA Foot and Ankle
    Los Angeles, California 90010, United States
  • Casa Colina
    Pomona, California 91769, United States
  • Center for Clincal Research
    San Francisco, California 94115, United States
  • Southernmost Foot and Ankle Specialists
    Homestead, Florida 33030, United States
  • Doctor's Research Network
    South Miami, Florida 33143, United States
  • Gateway Clinical Trials
    O'Fallon, Illinois 62269, United States
  • Foot and Ankle Center of Illinois
    Springfield, Illinois 62704, United States
  • Mercy Medical Center
    Cedar Rapids, Iowa 52403, United States
  • Foot and Ankle Specialists of the Mid Atlantic
    Frederick, Maryland 21703, United States
  • Wound Care Experts
    Las Vegas, Nevada 89148, United States
  • Lower Extremity Institute for Research and Therapy
    Youngstown, Ohio 44512, United States
  • Wound Centrics
    Corpus Christi, Texas 78404, United States
  • PULSE: Amputation Prevention Center, LLC
    El Paso, Texas 79902, United States
  • Foot and Ankle Specialists of the Mid Atlantic
    Salem, Virginia 24153, United States
  • United Wound Healing P.S
    Auburn, Washington 98092, United States
09

References and documents

Publications

  • Armstrong DG, Orgill DP, Galiano RD, Lantis J, Glat PM, Gitterle M, Carter MJ, Young N, Zelen CM. A Borate-Based Bioactive Glass Advances Wound Healing in Non-Healing Wagner Grade 1 Diabetic Foot Ulcers: A Randomised Controlled Clinical Trial. Int Wound J. 2025 Oct;22(10):e70763. doi: 10.1111/iwj.70763. PubMed 41014175 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in Jan 2025, 28 months.

Results were first posted in Nov 2025, 9 months after primary completion.

Of 103 industry-sponsored interventional studies with no phase under Diabetic Foot, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's 28 months is above that.

Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
May 3, 2024
First posted
May 8, 2024
StartActual
Sep 13, 2022
Primary completionActual
Jan 17, 2025
CompletionActual
Jan 17, 2025
Results first posted
Nov 10, 2025
Last update
Nov 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06403605
Lead sponsor
ETS Wound Care, LLC
Collaborators
Professional Education and Research Institute
Responsible party
Sponsor
First posted
May 8, 2024
Start date
Sep 13, 2022
Primary completion
Jan 17, 2025
Completion
Jan 17, 2025
Results posted
Nov 10, 2025
Last update
Nov 10, 2025

Study contacts

David Armstrong, DPM, MD, PhD
study chair · USC/Salsa
Charles M Zelen, DPM
principal investigator · Professional Education and Research Institute
Robert Galiano, MD
study chair · Professor of Surgery, Plastic Surgery, Northwestern University School of Medicine, Chicago, IL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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