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NCT07086443 · ClinicalTrials.gov registry record · Phase 4
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
A Phase 4 study of Diabetic Foot Ulcer and Diabetic Foot Ulcer (DFU), sponsored by Sequence LifeScience.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 350
- Enrollment target
- 1
- Study location
NCT07086443: Recruiting Phase 4 study of Diabetic Foot Ulcer and Diabetic Foot Ulcer (DFU), sponsored by Sequence LifeScience.
NCT07086443 is a Phase 4 study of Diabetic Foot Ulcer and Diabetic Foot Ulcer (DFU) that is actively recruiting participants, run by Sequence LifeScience. The registered enrollment target is 350 participants, above the 250-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (40% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07086443, a Phase 4 study of Diabetic Foot Ulcer and Diabetic Foot Ulcer (DFU), is actively recruiting participants, sponsored by Sequence LifeScience.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 350 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.
Primary Outcome
To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.
Conditions Studied
Interventions
- OTHER Activate™ Matrix
- OTHER AmnioDefend™ FT Matrix
- OTHER Palisade™ DM Matrix
- OTHER Enclose™ TL Matrix
- OTHER Sentry™ SL Matrix
Study Locations (1)
Pennsylvania
- Serena Group- Monroeville - Monroeville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2025-07-11 |
| Est. Completion | 2027-07 |
| Phase | Phase 4 |
What NCT07086443 shows while recruiting
NCT07086443 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, above the 250-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (40% higher).
The record links to 7 conditions, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 5 interventions - of which Activate™ Matrix is the first listed.
NCT07086443 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT07086443 about?
NCT07086443 is a clinical study titled "Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy". The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.
What is the current status of trial NCT07086443?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 350 participants. The study started on 2025-07-11. Estimated completion is 2027-07.
What conditions does trial NCT07086443 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer, Diabetic Foot Ulcer (DFU), Ulcer, Ulcer Foot, DFU.
What interventions are being tested in trial NCT07086443?
The interventions under investigation include: Activate™ Matrix (OTHER), AmnioDefend™ FT Matrix (OTHER), Palisade™ DM Matrix (OTHER), Enclose™ TL Matrix (OTHER), Sentry™ SL Matrix (OTHER).
Who is sponsoring clinical trial NCT07086443?
This trial is sponsored by Sequence LifeScience, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07086443 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 NCT07086443's enrollment target sits among peer trials
350 7th of 67 higher than 60 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
-
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
-
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
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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