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NCT03947450 · ClinicalTrials.gov registry record · Phase 2
Autologous Volar Fibroblast Injection Into the Stump Site of Amputees
A Phase 2 study of Amputation and Skin Wound, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03947450: Recruiting Phase 2 study of Amputation and Skin Wound, sponsored by Johns Hopkins University.
NCT03947450 is a Phase 2 study of Amputation and Skin Wound that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 50 participants, below the 132-participant average among 65 other Amputation trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03947450, a Phase 2 study of Amputation and Skin Wound, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a clinical trial testing the safety and efficacy of volar fibroblast (skin cells from the palm or sole) injections for thickening the epidermal (skin) layer at the stump site in people with below the knee amputations. The study will enroll adults seen at Johns Hopkins.
Primary Outcome
To determine the safety of the use of autologous volar fibroblasts to reprogram non-volar to volar-like epidermis with larger cytoplasmic area in human participants. The investigators will measure the numbers of hospitalizations which are related to the study. The occurrence of any study related hospitalization will be counted as one.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Autologous Skin Fibroblasts
Study Locations (1)
Maryland
- Department of Dermatology at Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2019-09-05 |
| Est. Completion | 2028-04-01 |
| Phase | Phase 2 |
What NCT03947450 shows while recruiting
NCT03947450 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 132-participant average among 65 other Amputation trials with a reported enrollment target (62% lower).
The record links to 3 conditions, with Amputation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03947450 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03947450 about?
NCT03947450 is a clinical study titled "Autologous Volar Fibroblast Injection Into the Stump Site of Amputees". This study is a clinical trial testing the safety and efficacy of volar fibroblast (skin cells from the palm or sole) injections for thickening the epidermal (skin) layer at the stump site in people with below the knee amputations. The study will enroll adults seen at Johns Hopkins.
What is the current status of trial NCT03947450?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2019-09-05. Estimated completion is 2028-04-01.
What conditions does trial NCT03947450 study?
This clinical trial studies the following conditions: Amputation, Skin Wound, Stem Cell.
What interventions are being tested in trial NCT03947450?
The interventions under investigation include: Placebo (BIOLOGICAL), Autologous Skin Fibroblasts (BIOLOGICAL).
Who is sponsoring clinical trial NCT03947450?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03947450 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amputation
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 NCT03947450's enrollment target sits among peer trials
50 16th of 65 higher than 49 of 65 other Amputation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amputation 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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