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

NCT02344329 | Unknown Phase 4

• 1 other identifier: TCC-104
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Diabetic Foot Ulcers; Diabetes

Outcome Measures

Primary Outcomes (1)

• Time to closure of a Diabetic Foot Ulcer using Human Amnion Allograft and Total Contact Casting vs Standard Wound Care and Total Contact Casting.

  Number of days to closure of the DFUs.

  12 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

TCC-EZ and Standard Wound Care (Topical wound dressing) Two dressing and cast changes in week one followed by weekly applications until 12 weeks or closure which ever occurs first. Usual wound care would involve assessment, debridement, moist wound environment, and off-loading.

Device: Topical wound dressing; Other: usual wound care

Intervention

EXPERIMENTAL

TCC-EZ and Human Amnion Allograft One dressing and two cast changes in week one followed by dressing change every two to three weeks and weekly cast changes until 12 weeks or closure which ever occurs first. Usual wound care would involve assessment, debridement, moist wound environment, and off-loading.

Biological: Human Amnion Allograft; Other: usual wound care

Interventions

Topical wound dressing DEVICE

Topical Wound Dressing

Control

Human Amnion Allograft BIOLOGICAL

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

Also known as: AmnioExCel

Intervention

usual wound care OTHER

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

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of North Dakota: lead

Study Sites (1)

Altru Health System

Grand Forks, North Dakota, 58202, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Interventions

Bandages

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Patricia A Thompson, MS,RN

  University of North Dakota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 22, 2015
• Study Start: August 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

US (1)