Autologous Volar Fibroblast Injection Into the Stump Site of Amputees
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Amputation
- Skin Wound
- Stem Cell
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Single arm crossover, subjects will be randomized 1:1 into whole stump injections of volar fibroblasts and vehicle injections respectively. Subjects will be blinded to which injections they will receive. At the end of the study, subjects who received vehicle injections will be notified and offered whole stump volar fibroblast injections. Blinding will occur for research staff both during measurements of epidermal thickness/area. If the PI or subject determines that they do not qualify for whole stump injection, do not desire whole stump injection, or are already enrolled as localized stump injections- the study will continue as a parallel interventional study model in which 2 locations are selected for fibroblast and vehicle injections on the same subject. Subjects who receive localized injections will be offered whole stump fibroblast injection at the end of the study.Masking: Double (Participant, Outcomes Assessor)Masking Description: In whole stump injection subjects: Subjects will be blinded to which injections they will receive. At the end of the study, subjects who received vehicle injections will be notified and offered whole stump volar fibroblast injections. Blinding will occur for outcomes assessor during measurements of epidermal thickness/area. In localized injection subjects: Sites were labeled as A and B, and mask for outcome assessors and subjects. All these are in the same subject.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
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. The investigator...
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. The investigators have demonstrated that injection of fibroblasts (from the palm or sole) is safe in healthy adults and potentially enhances palm or sole features in skin cells in areas other than the palm and sole. In a prior study, healthy adults injected with fibroblasts (from the palm or sole) experienced more firm skin at the injection site. The objective of this study is to determine if fibroblast (from palm or sole) injections are safe and effective at increasing epidermal thickness and skin firmness at the stump site in below the knee amputees. Outcomes are assessed via questionnaires, non-invasive imaging devices, and non-invasive skin firmness measuring devices. Injections will be targeted to the entire stump (unless determined otherwise by the PI and participant), including pressure intolerant areas of the skin that come into contact with the prosthetic socket, a region that is prone to skin irritation and breakdown, We will evaluate the most effective approach to administering this intervention via injections to the entire stump and the safety and effectiveness of whole stump injections and their effects on prosthesis use, skin breakdown, quality of life, and activity level. The investigators hope that information from this study will help with problems like skin breakdown in patients with amputations and prosthetics. The skin at the stump was not meant to withstand the pressure and friction of prosthetics and this study is the first step in trying to convert stump skin to palm/sole-like skin.
Tracking Information
- NCT #
- NCT03947450
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Luis Garza, MD PhD Johns Hopkins University
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