A Comparative Efficacy Study: Treatments of Non-Healing Diabetic Foot Ulcers

VA Office of Research and Development1 site in 1 country120 target enrollmentOctober 1, 2011

ConditionsDiabetic Foot Ulcer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diabetic Foot Ulcer
Sponsor: VA Office of Research and Development
Enrollment: 120
Locations: 1
Primary Endpoint: Wound Closure by Week 15
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to assess the effectiveness of cellular dermal replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that these devices are of equal efficacy.

Registry

clinicaltrials.gov

Start Date

October 1, 2011

End Date

April 4, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

VA Office of Research and Development

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•(Answering NO will exclude patient):
•An Institutional Review Board (IRB) Informed Consent Form signed and dated prior to any study-related activities.
•The area of the study ulcer after debridement is between 1 cm2 and 25 cm2 at Visit 3/Week
•Subjects between 18 and 85 years of age.
•Subject's highest Ankle-Brachial Pressure Index (ABPI) / Ankle-Arm Index (AAI) is greater than or equal to 0.80 and lower than 1.4 (the highest ABPI/AAI value from three measurements within last 6 months shall apply).or a toe-arm index is equal to or higher than 0.
•The patient has one or more diabetic ulcers on the target foot with only one ulcer selected as the study (target) ulcer. The target ulcer must be at least 4 cm from a non-target ulcer and in the Investigator's opinion, be unlikely to coalesce with another ulcer within 12 weeks of randomization.
•Subject's study ulcer is full thickness and does not extend to bone, muscle, or tendon.
•Subject's study ulcer has been present at least 4 weeks prior to the initial screening (Visit 1) or 6 weeks at randomization (Visit 3).
•Subject has been diagnosed with Type 1 or Type 2 diabetes and HbA1c is less than 10%.
•Study ulcer has no clinical feature of infection (2 signs of inflammation and elevated bacterial load of the wound).

Exclusion Criteria

•(Answering YES will exclude patient):
•The subject is diagnosed with cancer and is undergoing treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment.
•The subject is diagnosed with HIV/AIDS.
•The subject is diagnosed with any bleeding disorders.
•The subject is diagnosed with any connective tissue diseases.
•For female subjects, the subject is pregnant or lactating.
•The subject has a history of illicit drug use within one year of enrollment.
•In the past year, the subject experiences episodes of drinking more than 5 alcoholic beverages in less than two hours and/or drinking alcohol has become a problem in interpersonal relationships, work, driving and/or their behavior in general.
•The subject has any active infected wounds or osteomyelitis (confirmed by bone biopsy, MRI or bone scan).
•Doppler exam within the last 365 days demonstrating reflux greater than 0.5 seconds.