A Comparison of TCC-EZ Using Human Amnion Allograft vs TCC-EZ and Standard Wound Care in Treating Diabetic Foot Ulcers.

Status unconfirmed · Phase 4

Conditions studied: Diabetic Foot Ulcers, Diabetes

In brief

A Comparison of AmnioExcel® and Total Contact Casting (TCC-EZ) Versus Standard Wound Care and TCC-EZ in Treating Diabetic Foot Ulcers Best practice is to treat DFUs with standardized care and, if unsuccessful, use advanced modalities. This prospective clinical trial will compare healing rates between two treatment modalities in patients with DFUs in an ambulatory wound care clinic. The treatments are Total Contact Cast (TCC-EZ) with AmnioExcel® and TCC-EZ with standard treatment. Adult participants 18 years or older with a diabetic foot ulcer located on the plantar surface and \>1 cm in diameter will be asked by the Altru Wound Care Clinic MD or Family Nurse Practitioner visit to participate in the study if they have not demonstrated a 50% in reduction in wound area after two weeks of standard treatment. For those potential subjects who do not have 3rd party reimbursement the cost of the product and application will be covered by the respective company. They must be cognitively intact as evaluated by wound clinic primary care providers. Participants must agree to use the study treatments as directed, and to keep clinic visits during the 12-week trial or until the ulcer closes, whichever comes first.

Key facts

Study ID

NCT02344329

Run by

University of North Dakota

People needed

12

Starts

2014-08-01

Expected to finish

2017-11-01

Last updated by the study team

2017-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects will be included if they are 18 years of age or older
• have a diagnosis of diabetes type 1 or 2
• random blood sugar of 450 or < and HbA1c of 15% or < drawn quarterly prior to study
• the ulcer has been present for a minimum of 2 weeks under the current investigators care
• the foot ulcer is on the plantar surface of the forefoot or heel and > 0.5cm2 in size at day 0
• patient's ulcer extends through the dermis into subcutaneous tissue but without exposure of bone or joint capsule classified as a grade 2 or 3 DFU using the University of Texas diabetic wound classification system
• ulcer is free of necrotic debris and appears to be made up of healthy vascularized tissue
• and subject's foot has evidence of adequate perfusion with an ankle-brachial index of > 0.7 and < 1.2.-

You may not qualify if…

• Subjects younger that 18 years of age
• no current diagnosis of diabetes type 1 or 2
• has uncontrolled hyperglycemia random blood sugar of > 450 mg/dl
• HbA1c > 15%
• gangrene present on any part of the affected foot
• ulcer's total surface area is > 20cm2
• ulcer has decreased or increased in size by 50% or more during the screening period
• presence of non-study ulcer located within 7.0 cm of the study ulcer at the beginning of the study day 0
• and evidence of infection determined by the provider.

Where it is running

• Altru Health System — Grand Forks, North Dakota, United States

Full record on ClinicalTrials.gov

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