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NCT06437028 · ClinicalTrials.gov registry record · NA
Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.
A NA study of Diabetic Foot Ulcer, sponsored by Samaritan Biologics.
- Recruiting
- Registry status
- NA
- Development phase
- 170
- Enrollment target
- 1
- Study location
NCT06437028: Recruiting NA study of Diabetic Foot Ulcer, sponsored by Samaritan Biologics.
NCT06437028 is a NA study of Diabetic Foot Ulcer that is actively recruiting participants, run by Samaritan Biologics. The registered enrollment target is 170 participants, below the 252-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06437028, a NA study of Diabetic Foot Ulcer, is actively recruiting participants, sponsored by Samaritan Biologics.
- RECRUITING
- Registry status
- NA
- Development phase
- 170 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does the use of perinatal tissue allografts in conjunction with standard of care wound management techniques result in a higher percentage of target ulcers achieving complete closure (i.e. healing) as compared to ulcers being treated with standard of care alone after 12 weeks of treatment. One ulcer on each participant's foot will receive weekly 1) applications of perinatal tissue allografts and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life and their quality of life.
Primary Outcome
The percentage of wounds completely healed. Complete healing will be defined as 100% epithelialization without drainage and need for dressing or wound size ≤ 0.1cm\^2 as determined by the site investigator and validated by a blinded review board.
Conditions Studied
Interventions
- OTHER Standard of care
- OTHER Dual-layer perinatal tissue allograft
- OTHER Three-layer fenestrated perinatal tissue allograft
Study Locations (1)
North Carolina
- Monroe Biomedical Research - Monroe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2025-05-09 |
| Est. Completion | 2026-09 |
| Phase | NA |
What NCT06437028 shows while recruiting
NCT06437028 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, below the 252-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (33% lower).
The record links to 1 condition, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 3 interventions - of which Standard of care is the first listed.
NCT06437028 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06437028 about?
NCT06437028 is a clinical study titled "Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.". The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does the use of perinatal tissue allografts in conjunction with standard of care wound ma...
What is the current status of trial NCT06437028?
This trial is currently recruiting. It is a NA study. The enrollment target is 170 participants. The study started on 2025-05-09. Estimated completion is 2026-09.
What conditions does trial NCT06437028 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer.
What interventions are being tested in trial NCT06437028?
The interventions under investigation include: Standard of care (OTHER), Dual-layer perinatal tissue allograft (OTHER), Three-layer fenestrated perinatal tissue allograft (OTHER).
Who is sponsoring clinical trial NCT06437028?
This trial is sponsored by Samaritan Biologics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06437028 being conducted?
This trial has 1 study location across North Carolina. 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 NCT06437028's enrollment target sits among peer trials
170 22nd of 67 higher than 44 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
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