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Tests treatment safety and results for Amputation
Official title Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees.
ClinicalTrials.gov ID: NCT04839497
What this study is testing
What is Autologous Volar Fibroblast Injection into the Terminal Limb of Amputees?
Autologous Volar Fibroblast Injection into the Terminal Limb of Amputees is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for amputation.
Also referred to as Autologous Volar Fibroblast Treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Ages 18 to 75, inclusive
- Must have a transtibial amputation
- Must be using a prosthesis within the vicinity of 3 months or have had osteo-integration of a prosthetic in place for 1 month
- In the opinion of the investigator, must be medically able to undergo the administration of study material determined by laboratory tests obtained up...
- Able to provide written informed consent
You likely can't join if
- A skin erosion deeper than the skin dermis.
- Ulcers exceeding 4cm in diameter or 2cm in radius
- Non circular ulcers that cannot tolerate a 1cm margin at all sides
- Having received any investigational drug within 30 days prior to study entry
- An allergy history to any study materials including local anesthetic, dimethyl sulfoxide, human albumin, or bovine constituents, hetastarch, or EMLA...
- Pregnant, lactating, or trying to become pregnant
See the full eligibility criteria
- Ages 18 to 75, inclusive
- Must have a transtibial amputation
- Must be using a prosthesis within the vicinity of 3 months or have had osteo-integration of a prosthetic in place for 1 month
- In the opinion of the investigator, must be medically able to undergo the administration of study material determined by laboratory tests obtained up to 14 days before baseline for which the investigator identified no...
- Able to provide written informed consent
- Females of childbearing potential must: have a negative pregnancy test at screening agree to not become pregnant or breastfeed for the period of the study through 1 month after completion of the study be willing to use...
- Has healthy skin on the residual limb and is free of severe and active skin disease (excluding those on the residual limb) such as extreme and active eczema or psoriasis, active non-healing wounds, lichen planus, a...
- Willing and able to comply with the scheduled visits, biopsy/injection procedures, wound care instructions treatment plan, and other study procedures for the duration of the study.
- A skin erosion deeper than the skin dermis.
- Ulcers exceeding 4cm in diameter or 2cm in radius
- Non circular ulcers that cannot tolerate a 1cm margin at all sides
- Having received any investigational drug within 30 days prior to study entry
- An allergy history to any study materials including local anesthetic, dimethyl sulfoxide, human albumin, or bovine constituents, hetastarch, or EMLA (lidocaine 2.5% and prilocaine 2.5%).
- Pregnant, lactating, or trying to become pregnant
- A history of keloid formation
- Having a significant medical history that the investigator feels is not safe for study participation (for example, some forms of autoimmune conditions, metastatic cancer, infectious diseases such as HIV, HTLV I/II...
- Autoimmune diseases affecting the skin such as lupus.
- Presence of necrotic ischemic tissue on any stump ulcers, and/or capillary refill on stump skin of greater than 3 seconds
- Active infection of the residual limb (e.g. osteomyelitis, wound or skin condition with surrounding swelling, erythema, drainage, pain, gangrenous tissue or fever).
- Active smoker during the study (this includes e cigarettes and any type of tobacco use)
- We will also exclude those who are on chronic immunosuppressive therapies such as oral steroids, but also those on chronic topical steroids in the area of investigation.
- Amputees with symptomatic neuromas of the terminal limb within the last 3 months.
- Known bleeding disorder.
- Have a history of congenital or idiopathic methemoglobinemia, glucose-6-phosphate deficiencies, or use of medications associated with drug-induced methemoglobinemia. (specifically: Sulfonamides, Acetaminophen...
- Quadriplegics
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.