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CompletedNCT01656889Updated Mar 14, 2016Results posted

Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers

A Phase 3 interventional study of HP-802-247 and Vehicle in Venous Leg Ulcers, sponsored by Healthpoint. Completed at 50 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-14.

Sponsored by Healthpoint · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
447
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.

02

Conditions studied

  • Venous Leg Ulcers

Keywords

  • Venous leg ulcer
  • ulcer
  • venous stasis
  • compression
  • venous
  • venous stasis ulcer
  • vlu
03

In context

Varicose Ulcer

378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.

This study's enrollment of 447 is above the median of 64 across 325 interventional studies indexed under Varicose Ulcer.

Browse Varicose Ulcer studies →

Lead sponsor

Healthpoint is the lead sponsor of 33 studies on the registry; none 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

Inclusion criteria

  • Provide informed consent.
  • Age ≥ 18 years and of either sex.
  • Willing to comply with protocol instructions, including allowing all study assessments.
  • Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 12.0 cm2
  • Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
  • Arterial supply adequacy confirmed
  • Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone.
  • Target ulcer duration ≥ 6 weeks but ≤ 104 weeks (24 months).
  • Acceptable state of health and nutrition

Exclusion criteria

Exclusion Criteria:

  • History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B.
  • Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication.
  • Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
  • A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
  • Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
  • Refusal of or inability to tolerate compression therapy.
  • Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
  • History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
  • Any prior exposure to HP802-247 or its vehicle.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
447 participants (actual)

Study arms

  • Experimental
    HP802-247

    HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.

    Biological: HP-802-247

  • Placebo comparator
    Vehicle

    Vehicle Control (fibrinogen solution \& thrombin solution without cells)

    Biological: Vehicle

Interventions

  • BiologicalHP-802-247

    HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.

  • BiologicalVehicle

    (fibrinogen solution \& thrombin solution without cells)

06

What researchers measure

Primary outcomes

  1. Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline

    For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.

    Time frame: 12 Weeks

Secondary outcomes

  1. Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.

    This key secondary outcome was based on a Cox Proportional Hazard Analysis and a Kaplan-Meier survival analysis.

    Time frame: 12 Weeks

  2. Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline

    Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.

    Time frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first

  3. Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure

    Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.

    Time frame: Target ulcer status observed at two and three months following initial ulcer closure.

  4. Change in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks

    Target leg pain were measured using a Visual Analog Scale \[Range: 0mm - 100mm\]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.

    Time frame: Weekly, over the 12 week treatment period, baseline

  5. Change in Target Ulcer Pain

    Target ulcer pain were measured using a Visual Analog Scale \[Range: 0mm - 100mm\]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.

    Time frame: Weekly, over 12 week treament period, baseline

  6. Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on the Median Time (in Days) to Closure Over the 12-Week Treatment Period From Baseline.

    This key secondary outcome was based on a Kaplan-Meier survival analysis.

    Time frame: 12 weeks

07

Results

Posted Mar 14, 2016

Participant flow

Subjects were screened at 43 sites in the US and 5 in Canada; between August 22, 2012 and April 18, 2014; sites included independent and hospital wound clinics and private practice sites.

Treatment Period, 12 Weeks
Participant flow — Treatment Period, 12 Weeks
MilestoneHP802-247Vehicle
Started222225
Completed210214
Not completed1211
Withdrew: Adverse event104
Withdrew: Death01
Withdrew: Lost to follow-up11
Withdrew: Withdrawal by subject12
Withdrew: Protocol violation01
Withdrew: Moved out of the area02
Post Treatment Follow-Up, 3 Months
Participant flow — Post Treatment Follow-Up, 3 Months
MilestoneHP802-247Vehicle
Started210213
Completed206204
Not completed49
Withdrew: Death15
Withdrew: Lost to follow-up12
Withdrew: Withdrawal by subject21
Withdrew: Site closure01

Outcome measures

PrimaryCompare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline

For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.

Time frame:
12 Weeks
Reported as:
Number · participants
Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline
participantsHP802-247Vehicle
Wound Closed129126
Wound Not Closed8284
Statistical analysis
  • HP802-247 vs Vehicle · Cochran-Mantel-Haenszel · p = 0.5896P-value is based on the chi-squared proportion of wounds closed in each group.
SecondaryCompare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.

This key secondary outcome was based on a Cox Proportional Hazard Analysis and a Kaplan-Meier survival analysis.

Time frame:
12 Weeks
Reported as:
Median · days
Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.
daysHP802-247Vehicle
Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.57.0 (8.0 to 115)50.0 (6 to 134)
Statistical analysis
  • HP802-247 vs Vehicle · Regression, Cox · p = .3675
SecondaryCompare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline

Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.

Time frame:
Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first
Reported as:
Number · percentage of Closed Ulcers
Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline
percentage of Closed UlcersHP802-247Vehicle
Baseline00
Treatment Week 012.41.9
Treatment Week 025.79.5
Treatment Week 0313.319.5
Treatment Week 0423.732.4
Treatment Week 0531.838.1
Treatment Week 0638.944.3
Treatment Week 0740.847.6
Treatment Week 0846.452.9
Treatment Week 0949.355.2
Treatment Week 1053.655.7
Treatment Week 1157.860.0
Treatment Week 1263.062.4
Statistical analysis
  • HP802-247 vs Vehicle · Cochran-Mantel-Haenszel · p = 0.6426
  • HP802-247 vs Vehicle · Cochran-Mantel-Haenszel · p = .3843
  • HP802-247 vs Vehicle · Cochran-Mantel-Haenszel · p = 0.2792
  • HP802-247 vs Vehicle · Cochran-Mantel-Haenszel · p = 0.1502
  • HP802-247 vs Vehicle · Cochran-Mantel-Haenszel · p = 0.3823
  • HP802-247 vs Vehicle · Cochran-Mantel-Haenszel · p = 0.5528
  • HP802-247 vs Vehicle · Cochran-Mantel-Haenszel · p = .02913
  • HP802-247 vs Vehicle · Cochran-Mantel-Haenszel · p = 0.3896
  • HP802-247 vs Vehicle · Cochran-Mantel-Haenszel · p = 0.3989
  • HP802-247 vs Vehicle · Cochran-Mantel-Haenszel · p = 0.8682
  • HP802-247 vs Vehicle · Cochran-Mantel-Haenszel · p = 0.8083
  • HP802-247 vs Vehicle · Cochran-Mantel-Haenszel · p = 0.6687
SecondaryNumber of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure

Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.

Time frame:
Target ulcer status observed at two and three months following initial ulcer closure.
Reported as:
Number · participants
Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure
participantsHP802-247Vehicle
Follow-up Visit 1 (2 months), Wounds Closed120114
Follow-up Visit 1 (2 months), Wounds Reopened1418
Follow-up Visit 2 (3 months), Wounds Closed118112
Follow-up Visit 2 (3 months), Wounds Reopened1416
SecondaryChange in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks

Target leg pain were measured using a Visual Analog Scale \[Range: 0mm - 100mm\]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.

Time frame:
Weekly, over the 12 week treatment period, baseline
Reported as:
Least squares mean · units on a scale
Change in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks
units on a scaleHP802-247Vehicle
Week 01-3.74 ± 1.22-2.19 ± 1.22
Week 02-4.18 ± 1.39-4.03 ± 1.38
Week 03-6.14 ± 1.4-5.91 ± 1.39
Week 04-8.2 ± 1.42-6.71 ± 1.41
Week 05-10.6 ± 1.38-8.62 ± 1.37
Week 06-11.04 ± 1.53-8.2 ± 1.52
Week 07-11.57 ± 1.54-9.77 ± 1.53
Week 08-11.18 ± 1.53-10.65 ± 1.53
Week 09-12.7 ± 1.5-11.26 ± 1.49
Week 10-12.55 ± 1.52-11.2 ± 1.51
Week 11-12.35 ± 1.49-11.56 ± 1.48
Week 12-12.1 ± 1.49-12.27 ± 1.48
Statistical analysis
  • HP802-247 vs Vehicle · ANCOVA · p = 0.3601
  • HP802-247 vs Vehicle · ANCOVA · p = 0.9398
  • HP802-247 vs Vehicle · ANCOVA · p = 0.905
  • HP802-247 vs Vehicle · ANCOVA · p = 0.4471
  • HP802-247 vs Vehicle · ANCOVA · p = 0.3004
  • HP802-247 vs Vehicle · ANCOVA · p = 0.1815
  • HP802-247 vs Vehicle · ANCOVA · p = 0.399
  • HP802-247 vs Vehicle · ANCOVA · p = 0.8027
  • HP802-247 vs Vehicle · ANCOVA · p = 0.4913
  • HP802-247 vs Vehicle · ANCOVA · p = 0.5227
  • HP802-247 vs Vehicle · ANCOVA · p = 0.7032
  • HP802-247 vs Vehicle · ANCOVA · p = 0.9366
SecondaryChange in Target Ulcer Pain

Target ulcer pain were measured using a Visual Analog Scale \[Range: 0mm - 100mm\]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.

Time frame:
Weekly, over 12 week treament period, baseline
Reported as:
Least squares mean · units on a scale
Change in Target Ulcer Pain
units on a scaleHP802-247Vehicle
Week 01-5.08 ± 1.08-5.05 ± 1.08
Week 02-7.59 ± 1.25-6.95 ± 1.24
Week 03-10.32 ± 1.27-9.58 ± 1.26
Week 04-12.17 ± 1.3-10.26 ± 1.29
Week 05-13.15 ± 1.23-13.17 ± 1.22
Week 06-15.56 ± 1.35-13.03 ± 1.34
Week 07-15.8 ± 1.38-14.51 ± 1.37
Week 08-16.28 ± 1.38-14.81 ± 1.37
Week 09-17.16 ± 1.32-15.97 ± 1.31
Week 10-17.65 ± 1.32-15.91 ± 1.31
Week 11-17.34 ± 1.33-16.47 ± 1.32
Week 12-17.18 ± 1.36-16.39 ± 1.35
Statistical analysis
  • HP802-247 vs Vehicle · ANCOVA · p = 0.9853
  • HP802-247 vs Vehicle · ANCOVA · p = 0.7083
  • HP802-247 vs Vehicle · ANCOVA · p = 0.6744
  • HP802-247 vs Vehicle · ANCOVA · p = 0.2891
  • HP802-247 vs Vehicle · ANCOVA · p = 0.9923
  • HP802-247 vs Vehicle · ANCOVA · p = 0.1775
  • HP802-247 vs Vehicle · ANCOVA · p = 0.499
  • HP802-247 vs Vehicle · ANCOVA · p = 0.4423
  • HP802-247 vs Vehicle · ANCOVA · p = 0.5138
  • HP802-247 vs Vehicle · ANCOVA · p = 0.3409
  • HP802-247 vs Vehicle · ANCOVA · p = 0.6358
  • HP802-247 vs Vehicle · ANCOVA · p = 0.6753
SecondaryCompare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on the Median Time (in Days) to Closure Over the 12-Week Treatment Period From Baseline.

This key secondary outcome was based on a Kaplan-Meier survival analysis.

Time frame:
12 weeks
Reported as:
Median · days to wound closure
Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on the Median Time (in Days) to Closure Over the 12-Week Treatment Period From Baseline.
days to wound closureHP802-247Vehicle
Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on the Median Time (in Days) to Closure Over the 12-Week Treatment Period From Baseline.57.0 (8.0 to 115.0)50.0 (6.0 to 134.0)
Statistical analysis
  • HP802-247 vs Vehicle · Kaplan-Meier Survival analysis · p = < 0.05

Adverse events

Collected over Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-treatment period. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
HP802-247—17/222 (7.7%)119/222 (53.6%)
Vehicle—21/225 (9.3%)107/225 (47.6%)
Most frequent serious events
Showing 10 of 39
Most frequent serious events
EventHP802-247Vehicle
CellulitisInfections and infestations2/2224/225
SepsisInfections and infestations0/2222/225
Angina pectorisCardiac disorders1/2221/225
Arteriosclerosis coronary arteryCardiac disorders1/2220/225
Hypertensive heart diseaseCardiac disorders1/2220/225
Myocardial infarctionCardiac disorders1/2220/225
Gastrointestinal haemorrhageGastrointestinal disorders1/2220/225
PainGeneral disorders1/2220/225
Abscess limbInfections and infestations1/2220/225
Diabetic gangreneInfections and infestations1/2220/225
Most frequent other events
Showing 10 of 16
Most frequent other events
EventHP802-247Vehicle
Skin and Subcutaneous Tissue DisordersSkin and subcutaneous tissue disorders71/22250/225
Skin UlcerSkin and subcutaneous tissue disorders42/22231/225
Infections and InfestationsInfections and infestations39/22240/225
Injury, poisoining and procedural complicationInjury, poisoning and procedural complications27/22222/225
Musculoskeletal and Connective Tissue DisordersMusculoskeletal and connective tissue disorders19/22218/225
Pain in ExtremityMusculoskeletal and connective tissue disorders15/22210/225
General disorders and administration site conditionsGeneral disorders14/22211/225
Wound complicationInjury, poisoning and procedural complications9/22213/225
Nervous System DisordersNervous system disorders11/2228/225
Vascular DisordersVascular disorders11/2228/225

Baseline characteristics

ITT population

Age, Categorical
Age, Categorical(Participants)HP802-247VehicleTotal
<=18 years000
Between 18 and 65 years136138274
>=65 years7572147
Age, Continuous
Age, Continuous(years)HP802-247VehicleTotal
Mean60.5 ± 14.861.0 ± 12.560.7 ± 13.7
Sex: Female, Male
Sex: Female, Male(Participants)HP802-247VehicleTotal
Female7182153
Male140128268
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)HP802-247VehicleTotal
Hispanic or Latino364278
Not Hispanic or Latino175168343
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)HP802-247VehicleTotal
American Indian or Alaska Native101
Asian314
Native Hawaiian or Other Pacific Islander112
Black or African American433477
White160167327
More than one race000
Unknown or Not Reported3710
Region of Enrollment
Region of Enrollment(participants)HP802-247VehicleTotal
Canada91322
United States202197399
08

Study locations

50 sites
  • Glendale, Arizona 85306, United States
  • Phoenix, Arizona 85006, United States
  • Phoenix, Arizona 85012, United States
  • Tucson, Arizona 85723, United States
  • Tucson, Arizona 85724, United States
  • Carlsbad, California 92009, United States
  • Castro Valley, California 94546, United States
  • Fresno, California 93720, United States
  • Laguna Hills, California 92653, United States
  • Long Beach, California 90822, United States
  • Los Angeles, California 90095, United States
  • San Diego, California 92013, United States
  • San Francisco, California 94115, United States
  • Stockton, California 95204, United States
  • Sylmar, California 91342, United States
  • Washington, District of Columbia 20007, United States
  • Gainesville, Florida 32605, United States
  • Hialeah, Florida 33013, United States
  • Miami, Florida 33125, United States
  • South Miami, Florida 33143, United States
  • Tamarac, Florida 33321, United States
  • Chicago, Illinois 60611, United States
  • Chicago, Illinois 60612, United States
  • Chicago, Illinois 60616, United States
  • Jacksonville, Illinois 62650, United States
  • North Chicago, Illinois 60064, United States
  • Springfield, Illinois 62702, United States
  • Baltimore, Maryland 21224, United States
  • Boston, Massachusetts 02118, United States
  • Cambridge, Massachusetts 02138, United States
  • Las Vegas, Nevada 89119, United States
  • Emerson, New Jersey 07630, United States
  • New York, New York 10025, United States
  • Chapel Hill, North Carolina 27599, United States
  • Akron, Ohio 44307, United States
  • Tulsa, Oklahoma 74127, United States
  • Dunmore, Pennsylvania 18512, United States
  • Wyomissing, Pennsylvania 19610, United States
  • Dallas, Texas 75390, United States
  • Fort Worth, Texas 76104, United States
  • Fort Worth, Texas 76107, United States
  • San Antonio, Texas 78229, United States
  • St. George, Utah 84770, United States
  • Roanoke, Virginia 24013, United States
  • Tacoma, Washington 98431, United States
  • Vancovuer, British Columbia V5Z1M9, Canada
  • Hamilton, Ontario L8R2R3, Canada
  • London, Ontario N6C5J1, Canada
  • Sudbury, Ontario P3E5J1, Canada
  • Sherbrooke, Quebec J1H5N4, Canada
09

References and documents

Publications

  • Marston WA, Ennis WJ, Lantis JC 2nd, Kirsner RS, Galiano RD, Vanscheidt W, Eming SA, Malka M, Cargill DI, Dickerson JE Jr, Slade HB; HP802-247 Study Group. Baseline factors affecting closure of venous leg ulcers. J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):829-835.e1. doi: 10.1016/j.jvsv.2017.06.017. PubMed 29037354 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01656889
Lead sponsor
Healthpoint
Collaborators
Smith & Nephew, Inc.
Responsible party
Sponsor
First posted
Aug 3, 2012
Start date
Aug 2012
Primary completion
Dec 2014
Completion
Dec 2014
Results posted
Mar 14, 2016
Last update
Mar 14, 2016

Study contacts

Herbert B Slade, MD
study chair · Chief Medical Officer
Tommy Lee, MSHS
study director · Associate Director Clinical Operations
Robert Kirsner, MD
principal investigator · Investigator
William Marston, MD
principal investigator · Investigator

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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