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Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers

2016-07-27 03:38:21 | BioPortfolio

Summary

A Multicenter, Prospective, Randomized Controlled Comparative Parallel Study To determine the safety and effectiveness of EpiCord as compared to standard of care (SOC) therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs)

Description

This is a prospective, multicenter, randomized controlled trial. The trial will include approximately 66 subjects in up to 10 experienced clinical centers in the United States. The estimated enrollment period is 18 weeks (this includes the 2-week run-in period). After completing a 2-week screening period, the subjects will be followed for at least 16 weeks post-randomization.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diabetic Foot Ulcers

Intervention

EpiCord, Standard of Care

Location

Arizona Regional Medical Research (ARMR)
Tucson
Arizona
United States
85710

Status

Recruiting

Source

MiMedx Group, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-07-27T03:38:21-0400

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Medical and Biotech [MESH] Definitions

Common foot problems in persons with DIABETES MELLITUS, caused by any combination of factors such as DIABETIC NEUROPATHIES; PERIPHERAL VASCULAR DISEASES; and INFECTION. With the loss of sensation and poor circulation, injuries and infections often lead to severe foot ulceration, GANGRENE and AMPUTATION.

The minimum acceptable patient care, based on statutes, court decisions, policies, or professional guidelines.

Peripheral, autonomic, and cranial nerve disorders that are associated with DIABETES MELLITUS. These conditions usually result from diabetic microvascular injury involving small blood vessels that supply nerves (VASA NERVORUM). Relatively common conditions which may be associated with diabetic neuropathy include third nerve palsy (see OCULOMOTOR NERVE DISEASES); MONONEUROPATHY; mononeuropathy multiplex; diabetic amyotrophy; a painful POLYNEUROPATHY; autonomic neuropathy; and thoracoabdominal neuropathy. (From Adams et al., Principles of Neurology, 6th ed, p1325)

Devices used to support or align the foot structure, or to prevent or correct foot deformities.

Distortion or disfigurement of the foot, or a part of the foot, acquired through disease or injury after birth.

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