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NCT04839497 · ClinicalTrials.gov registry record · Phase 2
Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees.
A Phase 2 study of Amputation, sponsored by Major Extremity Trauma Research Consortium.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04839497 is a Phase 2 study of Amputation that is actively recruiting participants, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 20 participants, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04839497, a Phase 2 study of Amputation, is actively recruiting participants, sponsored by Major Extremity Trauma Research Consortium.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The study will enroll 20 adults ages 18-75 with a transtibial amputation with mature residual limbs who are ambulatory prosthesis users. Participants will be randomized to either treatment with low dose volar fibroblast injections (n=10) or to vehicle control (n=10). Participants will undergo a biopsy to harvest volar skin for fibroblast expansion and tattooing to identify injection sites on the residual limb. Fibroblasts will be processed at the Hopkins Cellular Therapy Core Lab and volar cells primed for injection will be sent to participating centers for administration. Participants randomized to the treatment group will be treated with low-dose cells. Injections will be administered on at least 1 and up to three separate days over the course of one week. Participants randomized to the vehicle control group will receive injection of cryoprotectant. All participants will be followed at 2 weeks, 1, 2, and 3 months after the last injection. These visits will include a clinical evaluation for complications, non-invasive assessments of skin firmness and thickness, skin appearance, and patient-reported outcomes. After the final monitoring visit, individuals randomized to the vehicle control group will have the opportunity to receive the volar fibroblast injections and will be followed for an additional 3 months. The investigators hypothesize that (1) There will be no difference in the rate of serious adverse events among patients treated with volar fibroblast injections compared with patients treated with vehicle control, and (2) Patients treated with volar fibroblast injections will have firmer skin on the residual limb compared with patients tread with vehicle alone.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Autologous Volar Fibroblast Injection into the Terminal Limb of Amputees
Study Locations (1)
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-09-26 |
| Est. Completion | 2027-01-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04839497
The ClinicalTrials.gov registry entry for NCT04839497 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (85% lower). The listed sponsor is Major Extremity Trauma Research Consortium, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Amputation appearing as the primary indexed condition, and to 1 intervention - of which Autologous Volar Fibroblast Injection into the Terminal Limb of Amputees is the first listed.
NCT04839497 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04839497 about?
NCT04839497 is a clinical study titled "Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees.". The study will enroll 20 adults ages 18-75 with a transtibial amputation with mature residual limbs who are ambulatory prosthesis users. Participants will be randomized to either treatment with low dose volar fibroblast injections (n=10) or to vehicle control (n=10). Participants will undergo a biop...
What is the current status of trial NCT04839497?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2022-09-26. Estimated completion is 2027-01-01.
What conditions does trial NCT04839497 study?
This clinical trial studies the following conditions: Amputation.
What interventions are being tested in trial NCT04839497?
The interventions under investigation include: Autologous Volar Fibroblast Injection into the Terminal Limb of Amputees (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04839497?
This trial is sponsored by Major Extremity Trauma Research Consortium, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04839497 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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