NCT02399826

Study of Amniotic Membrane Graft in the Management of Diabetic Foot Ulcers

A Prospective, Randomized, Comparative Parallel Study of Amniotic Membrane Graft in the Management of Diabetic Foot Ulcers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Lower Extremity Institute for Research and Therapy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is comparison trial comparing human amniotic membrane to standard wound care for non healing diabetic foot wounds over a 12 weeks period

Detailed description

This is a prospective, stratified, randomized, comparative, parallel group, Multi-center clinical trial comparing the proportion of ulcers completely healed by use of amniotic membrane graft (Amnioband)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 investigators will compare the proportion of ulcers completely healed by the amniotic membrane graft protocol of care to the standard protocol of care in the management of indolent diabetic ulcers at 6 weeks. In addition the investigators will compare the proportion of healing at 4 weeks, 12 weeks and, the mean time to healing, and the cost effectiveness of the two protocols of care. Mean time to healing will be measured by wound tracings.

Conditions

• Diabetic Foot
• Foot Ulcer; Diabetic

Interventions

Type	Name	Description
DEVICE	Offloading	Provision of an offloading cam walker or cast boot, may also convert to "total contact cast" and add felt or foam to supplement
PROCEDURE	Dressing Application	Application of a non adherent dressing, and a multi-layer compression dressing

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-01-01
• First posted: 2015-03-26
• Last updated: 2016-08-16

Locations

3 sites across 1 country: United States