Foot Ulcer, Diabetic Clinical Trial
— ProcentaOfficial title:
Use of Procenta® Conformable Barrier in Recovery of Non-Healing Foot & Ankle Ulcers in Patients With Diabetes Mellitus Types I and II
Verified date | October 2021 |
Source | The VA Western New York Healthcare System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Procenta® has been successful in facilitating closure of non-healing diabetic ulcers in patients where proper wound care management/practice has failed along with other allo- and xenografts. In each individual case study where diabetes mellitus was pathological, unique wound morphologies with high variability in all three dimensions showed significant progress or were fully closed after at least one application of Procenta®. In the present study, the investigators seek to investigate the efficacy of the product over a 90-day treatment time-course with a larger sample size of patients suffering from non-healing wounds due to diabetes mellitus types I or II (diabetes mellitus). As a result, the investigators hope to better understand the potential and limitations of the product under these conditions with the anticipation that a significant number of patients will recover, avoid amputation, and return to a normal daily life.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | March 1, 2022 |
Est. primary completion date | March 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 99 Years |
Eligibility | Inclusion Criteria: - Inclusion Criteria: - Patient must have a non-healing ulcer associated with diabetes mellitus - Ulcer must have a minimum surface area of 0.5cm2 and a maximum surface area of 10.0cm2 i. Wound depth is not a criterion, though it will be documented throughout the study - Failed conventional wound care treatments - Amputation candidate Exclusion Criteria: - Exclusion Criteria: - Co-morbidities which do not allow the ulcer to be linked to diabetic pathology will be excluded from the study o This is intended to limit the number of probable causes/contributing factors related to the ulcer. Commonly associated conditions, such as peripheral vascular disease is not an exclusion criterion, though it is documented in form, Enrollment Application Form for VAWNY072020PRODFU (IRB692.F01) - Wounds with active infections or gangrene - Active carcinoma(s) - Wounds where bone is necrosing, avascular necrosis - Multiple ulcers on the same foot/ankle |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The VA Western New York Healthcare System |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of Wound closure | Primary end points are percent of wound closure | through study completion, approximately 6 months |
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