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NCT07089602 · ClinicalTrials.gov registry record · Phase 4
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 study of Diabetic Foot Ulcer and Venous Leg Ulcer, sponsored by BioLab Holdings.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 650
- Enrollment target
- 1
- Study location
NCT07089602: Recruiting Phase 4 study of Diabetic Foot Ulcer and Venous Leg Ulcer, sponsored by BioLab Holdings.
NCT07089602 is a Phase 4 study of Diabetic Foot Ulcer and Venous Leg Ulcer that is actively recruiting participants, run by BioLab Holdings. The registered enrollment target is 650 participants, above the 245-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (165% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07089602, a Phase 4 study of Diabetic Foot Ulcer and Venous Leg Ulcer, is actively recruiting participants, sponsored by BioLab Holdings.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 650 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Standard of Care DFU
- OTHER Tri-Membrane Wrap™ DFU
- OTHER Membrane Wrap™ DFU
- OTHER Membrane Wrap-Lite™ DFU
- OTHER Membrane Wrap-Hydro™ DFU
Study Locations (1)
Pennsylvania
- Center for Foot and Ankle Disorders - Philidelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 650 participants |
| Start Date | 2025-07-15 |
| Est. Completion | 2027-07 |
| Phase | Phase 4 |
What NCT07089602 shows while recruiting
NCT07089602 is an interventional study that assigns participants to a tested intervention. The registered 650 participants enrollment target is mid-sized for trials with a published cap, above the 245-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (165% higher).
The record links to 9 conditions, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 5 interventions - of which Standard of Care DFU is the first listed.
NCT07089602 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT07089602 about?
NCT07089602 is a clinical study titled "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". 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.
What is the current status of trial NCT07089602?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 650 participants. The study started on 2025-07-15. Estimated completion is 2027-07.
What conditions does trial NCT07089602 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer, Venous Leg Ulcer, Diabetic Foot, Ulcer, Ulcer Foot.
What interventions are being tested in trial NCT07089602?
The interventions under investigation include: Standard of Care DFU (OTHER), Tri-Membrane Wrap™ DFU (OTHER), Membrane Wrap™ DFU (OTHER), Membrane Wrap-Lite™ DFU (OTHER), Membrane Wrap-Hydro™ DFU (OTHER).
Who is sponsoring clinical trial NCT07089602?
This trial is sponsored by BioLab Holdings, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07089602 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Foot Ulcer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07089602's enrollment target sits among peer trials
650 4th of 67 higher than 64 of 67 other Diabetic Foot Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
RECRUITING · Phase 4
-
Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)
RECRUITING · Phase 4
-
A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
RECRUITING · Phase 4
-
A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.
RECRUITING · Phase 4
-
Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.
RECRUITING · Phase 4
-
Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers
ACTIVE NOT RECRUITING · Phase 4
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