NCT02331147

Allogenic Dermis Versus Standard Care in the Management of Diabetic Foot Ulcers

A Prospective, Randomized, Comparative Parallel Study of Allogenic Dermis Graft in the Management of Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Musculoskeletal Transplant Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is comparison trial comparing human dermis to standard wound care for non healing diabetic wound

Detailed description

This is a prospective, randomized, comparative, parallel group, Multi-center clinical trial comparing the proportion of ulcers completely healed by use of allogenic dermal graft versus the standard protocol of wound care in diabetic patients with a diabetic foot ulcer with adequate arterial perfusion, for wound healing to the affected limb. The primary objective of this study is to compare the proportion of ulcers completely healed by the allogenic dermal graft protocol of care to the standard protocol of care in the management of indolent diabetic ulcers at 6 weeks. The secondary objectives of this study are to compare the proportion of healing at 4 weeks, 12 weeks and, the mean time to healing. Patient after signing IRB approve informed consent, upon meeting inclusion/exclusion criteria will be randomized into one of two group. One group receiving standard of care protocol, with an offloading boot, and one group received human allogenic dermis application, with compressive dressing and offloading boot. Patients will be seen weekly or until complete healing occurs. Measurements will be taken of the diabetic ulcers using the a centimeter ruler measuring length by width.

Conditions

• Diabetic; Foot Ulcers

Interventions

Type	Name	Description
OTHER	Offloading	Patient will be offloaded in a diabetic camboot after treatment
OTHER	Dressing Application	Application of a non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing.

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2015-01-06
• Last updated: 2022-06-01

Locations

3 sites across 1 country: United States