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RecruitingNCT07089602BIOCAMPUpdated Jul 28, 2025

Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers

A Phase 4 interventional study of Standard of Care DFU and Tri-Membrane Wrap™ DFU in Diabetic Foot, DFU and Diabetic Foot Ulcer, sponsored by BioLab Holdings. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-28.

Sponsored by BioLab Holdings · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
650
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers.

Read the detailed description

This study is a multi-center, prospective, randomized controlled clinical study consisting of 650 subjects from up to 30 centers. The subjects are randomized to receive 1 of 4 treatments, either with Tri-Membrane Wrap™ (HPM-1); Membrane Wrap™ (HPM-2); Membrane Wrap-Lite™ (HPM-3); Membrane Wrap-Hydro™ (HPM-4); and SOC. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of HPM-1 - HPM - 4 + SOC or SOC alone until or up to 12 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional for both arms, for the purpose of changing only (1) the secondary dressing in the HPM arm or (2) change the standard of care dressing in the control arm. A trial design diagram is found in Figure 3.

02

Conditions studied

  • Diabetic Foot
  • DFU
  • Diabetic Foot Ulcer
  • Foot Ulcer, Diabetic
  • Ulcer Foot
  • Venous Leg Ulcer
  • Leg Ulcer
  • Leg Ulcers Venous
  • 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 planned enrollment of 650 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

BioLab Holdings is the lead sponsor of 5 studies on the registry; 3 are 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
No

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

  • The potential subject must be at least 18 years of age or older.
  • The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
  • At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20 cm2 measured post debridement with the eKare inSight® imaging device.
  • The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit.
  • The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
  • The potential subject must have a target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.

  • The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:

    1. ABI between 0.7 and ≤ 1.3;
    2. TBI ≥ 0.6;
    3. TCOM ≥ 40 mmHg;
    4. PVR: biphasic.
  • If the potential 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.
  • The potential subject must consent to using the prescribed offloading method for the duration of the study.
  • The potential subject must agree to attend the weekly study visits required by the protocol.
  • The potential subject must be willing and able to participate in the process.

Exclusion Criteria: DFU

  • The potential subject is known to have a of \< 6 months.
  • The potential subject's target ulcer is not secondary to diabetes.
  • The target ulcer is infected or there is cellulitis in the surrounding skin.
  • The target ulcer exposes tendon or bone.
  • There is evidence of osteomyelitis complicating the target ulcer.
  • There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
  • The potential subject is receiving (including systemic at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
  • The potential subject is taking hydroxyurea.
  • The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
  • The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
  • The potential subject has (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.

  • The surface area of the potential subject's target ulcer has reduced in size by more than 40% in the 4 weeks prior to Treatment Visit 1 ("historical" run-in period*). OR The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit AND The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV-1 visit.

    a. eKare inSight® imaging device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable)

  • The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
  • The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
  • The potential subject has end stage renal disease requiring dialysis.
  • The potential subject has participated in a clinical trial involving treatment with an product within the previous 30 days.
  • The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
  • The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
  • The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.

Inclusion Criteria:VLU

  • The potential subject must be at least 21 years of age or older.
  • At enrollment, the potential subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 20 cm2 measured post-debridement.
  • The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care prior to the initial screening visit.

  • The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:

    1. ABI between 0.7 and ≤ 1.3;
    2. TBI ≥ 0.6;
    3. TCOM ≥ 40 mmHg;
    4. PVR: biphasic.
  • If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
  • The potential subject must agree to attend the weekly study visits required by the protocol.
  • The potential subject must be willing and able to participate in the informed consent process.

Exclusion criteria

Exclusion Criteria:

  • The potential subject is known to have a of \< 6 months.
  • The potential subject's target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
  • The potential subject's target ulcer exposes tendon or bone.
  • There is evidence of osteomyelitis complicating the potential subject's target ulcer.
  • The potential subject is receiving (including systemic at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
  • The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
  • The potential subject has (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.

  • The surface area of the potential subject's target ulcer has reduced in size by more than 40% in the 4 weeks prior to Treatment Visit 1 ("historical" run-in period*). OR The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit AND The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV-1 visit.

    a. *eKare inSight® imaging device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable)

  • The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
  • The potential subject has end stage renal disease requiring dialysis.
  • The potential subject has participated in a clinical trial involving treatment with an product within the previous 30 days.
  • A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
  • The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
  • The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
  • The potential subject has a wound with active or latent infection.
  • The subject has a disorder that would create unacceptable risk of post-operative complication.
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
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
650 participants (estimated)

Study arms

  • Active comparator
    DFU Standard of Care

    Debridement, reduction of bacterial burden, and proper moisture balance using dressings. Off-loading using the off-loading boot or total contact cast (TCC).

    Other: Standard of Care DFU

  • Experimental
    DFU Tri-Membrane Wrap™ + SOC

    Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.

    Other: Tri-Membrane Wrap™ DFU

  • Experimental
    DFU Membrane Wrap™ + SOC

    Membrane Wrap™ is an allograft derived from human amniotic membrane.

    Other: Membrane Wrap™ DFU

  • Experimental
    DFU Membrane Wrap-Lite™ + SOC

    Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.

    Other: Membrane Wrap-Lite™ DFU

  • Experimental
    DFU Membrane Wrap-Hydro™ + SOC

    Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane.

    Other: Membrane Wrap-Hydro™ DFU

  • Active comparator
    VLU Standard of Care

    Debridement, reduction of bacterial burden, and proper moisture balance using dressings. Compression using multilayer compression wraps.

    Other: Standard of Care VLU

  • Experimental
    VLU Tri-Membrane Wrap™ + SOC

    Tri-Membrane Wrap™ is an allograft derived from human amniotic membrane.

    Other: Tri-Membrane Wrap™ VLU

  • Experimental
    VLU Membrane Wrap™ + SOC

    Membrane Wrap™ is an allograft derived from human amniotic membrane.

    Other: Membrane Wrap™ VLU

  • Experimental
    VLU Membrane Wrap-Lite™ + SOC

    Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.

    Other: Membrane Wrap-Lite™ VLU

  • Experimental
    VLU Membrane Wrap-Hydro™ + SOC

    Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane.

    Other: Membrane Wrap-Hydro™ VLU

Interventions

  • OtherStandard of Care DFU

    Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

  • OtherTri-Membrane Wrap™ DFU

    Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

  • OtherMembrane Wrap™ DFU

    Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

  • OtherMembrane Wrap-Lite™ DFU

    Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

  • OtherMembrane Wrap-Hydro™ DFU

    Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

  • OtherStandard of Care VLU

    Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

  • OtherTri-Membrane Wrap™ VLU

    Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

  • OtherMembrane Wrap™ VLU

    Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

  • OtherMembrane Wrap-Lite™ VLU

    Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

  • OtherMembrane Wrap-Hydro™ VLU

    Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

06

What researchers measure

Primary outcomes

  1. Determine the between-arm difference percentage of subjects achieving complete closure of target ulcer over 12 weeks.

    To determine the between-arm difference of multiple Human Placental Membrane (HPM) products plus SOC versus SOC alone in achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers over 12 weeks using a modified dual platform (Matriarch) trial design. The initial plan is to evaluate several HPM per wound type; however, the modified platform design permits the inclusion of additional placental and umbilical cord derived products and can continue in perpetuity.

    Time frame: 1-12 Weeks

Secondary outcomes

  1. Time to Closure

    To determine the between-arm difference in the time to closure over 12 weeks for HPM plus SOC versus SOC alone.

    Time frame: 1-12 weeks

  2. Percent Area Reduction (PAR)

    To determine the between-arm difference in the percent area reduction (PAR) at weekly intervals for HPM plus SOC versus SOC alone.

    Time frame: 1-12 weeks

  3. Determine improvement in quality of life

    To determine the between-arm difference in the quality of life for subjects receiving HPM plus SOC compared to SOC alone using the Wound Quality of Life (wQOL) questionnaire. Scores on a scare from "Not at all" to "Very much."

    Time frame: 1-12 Weeks

  4. Pain in patients who present with VAS greater than 4

    To determine the between-arm difference in pain for patients that present with a Visual Analog Sale (VAS) score of greater than 4. The VAS has a scale of 0-10. 0 Meaning no pain and 10 being the worst pain.

    Time frame: 1-12 weeks

  5. Proportion of patients that reach complete closure over 65

    To determine the proportion of ulcers that heal in patients 65 years or older for HPM plus SOC versus SOC alone.

    Time frame: 1-12 weeks

  6. Functional Ambulatory Category Scale

    To evaluate the between-arm difference in functional ambulation based on Functional Ambulatory Category Scale (FACS) - VLU subjects only. FACS is a scale from 0-5, 5 being completely independent and ambulatory on all surfaces.

    Time frame: 1-12 Weeks

  7. Determine improvement in quality of life

    To determine the between-arm difference in the quality of life for subjects receiving HPM plus SOC compared to SOC alone using the Forgotten Wound Score (FWS) questionnaire. Forgotten wound scores situations on a scale of "never" to "mostly."

    Time frame: 1-12 Weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

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

Started Jul 2025 (actual). Primary completion is estimated for Jul 2027, 24 months after the start.

Of 21 phase 4 interventional studies under Diabetic Foot, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's planned 24 months is above that.

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

Registered
Jun 30, 2025
First posted
Jul 28, 2025
StartActual
Jul 15, 2025
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2027
Last update
Jul 28, 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 Jul 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07089602
Lead sponsor
BioLab Holdings
Collaborators
SerenaGroup, Inc.
Responsible party
Sponsor
First posted
Jul 28, 2025
Start date
Jul 15, 2025
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Jul 28, 2025

Study contacts

Bennett Sarver
Contact
bsarver@serenagroups.com
888-960-1343 ext. 1008
Thomas Serena
Contact
tserena@serenagroups.com
814-688-4000

Oversight

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

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