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NCT07290673 · ClinicalTrials.gov registry record · NA
Evaluating the Efficacy of FoundationDRS Solo in Addition to Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers
A NA study, sponsored by Samaritan Biologics.
- Not yet
- Registry status
- NA
- Development phase
- 124
- Enrollment target
NCT07290673: Clinical Trial NA study, sponsored by Samaritan Biologics.
NCT07290673 is a NA study that has not yet begun recruiting, run by Samaritan Biologics. The registered enrollment target is 124 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07290673, a NA study, has not yet begun recruiting, sponsored by Samaritan Biologics.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 124 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if using FoundationDRS Solo improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does FoundationDRS Solo, when used 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 applications of 1) FoundationDRS Solo 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.
Interventions
- OTHER Standard of Care
- OTHER FoundationDRS Solo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2026-04-01 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
What is known before NCT07290673 opens enrollment
NCT07290673 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT07290673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07290673 about?
NCT07290673 is a clinical study titled "Evaluating the Efficacy of FoundationDRS Solo in Addition to Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers". The goal of this clinical trial is to learn if using FoundationDRS Solo improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does FoundationDRS Solo, when used in conjunction with standard of care wound management technique...
What is the current status of trial NCT07290673?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 124 participants. The study started on 2026-04-01. Estimated completion is 2027-12-31.
What interventions are being tested in trial NCT07290673?
The interventions under investigation include: Standard of Care (OTHER), FoundationDRS Solo (OTHER).
Who is sponsoring clinical trial NCT07290673?
This trial is sponsored by Samaritan Biologics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07290673's enrollment target sits among peer trials
124 758th of 2000 higher than 1,239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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