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

NCT02344329 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-05-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Topical wound dressing

Topical Wound Dressing

BIOLOGICAL

Human Amnion Allograft

Change dressing every two to three weeks and TCC-EZ is changed weekly for 12 or until healed.

OTHER

usual wound care

assessment, wound cleansing, debridement, moist wound environment, and off-loading

Sponsors & Collaborators

  • University of North Dakota

    lead OTHER

Principal Investigators

  • Patricia A Thompson, MS,RN · University of North Dakota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02344329 on ClinicalTrials.gov