Use of Procenta® Conformable Barrier for Non-Healing Foot & Ankle Ulcers in Patients With Diabetes Mellitus Types I and II

NCT05099887 | Unknown

• 1 other identifier: 1591772
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Foot Ulcer, Diabetic

Outcome Measures

Primary Outcomes (1)

• Percent of Wound closure

  Primary end points are percent of wound closure

  through study completion, approximately 6 months

Study Arms (1)

wound application

OTHER

Application of Procenta as wound cover

Biological: Procenta conformable barrier

Interventions

Procenta conformable barrier BIOLOGICAL

Wound care dressing biologic allograft

wound application

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Co-morbidities which do not allow the ulcer to be linked to diabetic pathology will be excluded from the study
• Wounds with active infections or gangrene
• Active carcinoma(s)
• Wounds where bone is necrosing, avascular necrosis
• Multiple ulcers on the same foot/ankle

Sponsors & Collaborators

• The VA Western New York Healthcare System: lead

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: October 29, 2021
• Study Start: December 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share