Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT03947450
Eligibility Criteria:
Inclusion Criteria:
Patients interested in study participation must meet all of the following inclusion criteria:
* May be male or female
* Must be between 18 years and 65 years of age
* Must have a below the knee amputation.
* Must be using a prosthetic for 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 within 7 days before baseline for which the investigator identified no clinically significant abnormality.
* Be able to comprehend the informed consent document and provide consent for participation
* 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 a reliable form of contraception during the study
* Be 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.
Exclusion Criteria:
Patients meeting any of the following criteria will be ineligible for study participation:
* A skin erosion deeper than the skin dermis.
* 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, Hepatitis B, Hepatitis C). Biopsies taken from individuals with infections that are not allowed to enter the cell therapy core will make it such that these individuals cannot participate.
* Specifically we will exclude those with 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.
* Active smoker during the study
* 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.
* Recent amputee who has not yet been approved to use a prosthetic.
* Use of a prosthetic for less than 3 months.
* Amputees with neuromas of the terminal limb within the last 3 months.
* Known bleeding disorder.
* For those receiving Bellafill/collagen skin test: history of serious allergy, such as anaphylaxis.
* For whole stump injections: Have a history of congenital or idiopathic methemoglobinemia, glucose-6-phosphate deficiencies, or use of medications associated with drug-induced methemoglobinemia. (specifically: Sulfonamides, Acetaminophen, Acetanilid, Aniline dyes, Benzocaine, Chloroquine, Dapsone, Naphthalene, Nitrates and Nitrites, Nitrofurantoin, Nitroglycerin, Nitroprusside, Pamaquine, Para-aminosalicylic acid, Phenacetin, Phenobarbital, Phenytoin, Primaquine, or Quinine.)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03947450
Study Brief:
Protocol Section:
NCT03947450