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



Status:Recruiting
Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:August 2014
End Date:December 2016
Contact:Patricia A Thompson, MS,RN
Email:pat.thompson@und.edu
Phone:701-777-4501

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A Comparison of Total Contact Casting (TCC-EZ) Using Human Amnion Allograft (AmnioExcel) Versus Total Contact Casting (TCC-EZ) and Standard Wound Care in Treating Diabetic Foot Ulcers (TAD)

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.

A TCC offloads pressure and is the gold standard for DFU treatment, as documented in several
studies. The TCC results in an average healing rate of 80-90% within 6 weeks, yet only about
6% of DFU patients receive the TCC. The TCC requires special provider training for
application. Given the high efficacy and low complication risk for the TCC, clinicians need
to use the TCC to treat DFUs. Literature supports use of the TCC combined with other wound
bed treatment modalities. AmnioExCel® is a dehydrated, extracellular human amnion derived
tissue allograft that provides a structural tissue matrix that promotes angiogenesis,
collagen matrix formation and re-epithelization (Werber et al., 2013). This study will look
at whether or not combining AmnioExCel® and a TCC-EZ results in a better healing rate than
TCC-EZ and standard wound care.

Purpose/Research Questions:

The purpose of this prospective clinical trial is to compare healing rates between two
treatment modalities in patients with DFUs in an ambulatory wound care clinic. The
treatments are Total Contact Casting (TCC-EZ) with AmnioExCel® and TCC-EZ with standard
treatment.

Research Questions:

1. What is the difference in reduction in wound bed area for diabetic foot ulcers (DFUs)
treated with Total Contact Casting TCC-EZ and AmnioExCel® compared to those treated
with TCC-EZ and standard wound treatment?

2. What is the difference in time to closure for DFUs treated with TCC-EZ and AmnioExCel®
compared to those treated with TCC-EZ and standard wound treatment?

3. What is the difference in cost of treatment for a diabetic foot ulcer treated with
TCC-EZ and AmnioExCel® as compared to TCC-EZ with standard wound treatment?

4. What is the relationship between the hemoglobin A1c test(HbA1c) or glycated hemoglobin
test and reduction in wound bed area for DFUs treated with TCC-EZ and AmnioExCel®
compared to those treated with TCC-EZ and standard wound treatment?

5. What is the relationship between HbA1c and time to closure for DFUs with TCC-EZ and
AmnioExCel® compared to those treated with TCC-EZ and standard wound treatment?

6. What is the subjects' reported satisfaction using TCC-EZ?

7. What is the reoccurrence of DFUs in a 90 day post treatment follow up?

8. What are the characteristics of adverse side effects using TCC-EZ and AmnioExCel®?

Methods:

All patients in this study will receive 2 weeks of usual wound care consisting of wound
cleansing, removal of pressure (offloading), sharp debridement as needed, and maintenance of
a moist wound environment. If they have demonstrated less than a 50% improvement in
reduction in wound area of their DFU over 2 weeks, subjects will be approached for
participation in this study. If they agree to participate, they will be randomly assigned to
one of the two treatment groups. Treatment for Group A will consist of TCC-EZ® and
AmnioExCel® and treatment for Group B will consist of standard wound care and TCC-EZ® and
standard wound care. If the subject has more than one ulcer the largest ulcer will be used
for inclusion in the study. At the beginning and end of the study blood samples for HbA1c
will be taken and if the HbA1c is greater than 15%, subjects will be excluded or if random
blood sugar is greater than 450 mg/dl (Marston et al., 2003). Study participation will be
for 12 weeks or less if the wound closes before 12 weeks. DFUs not closed at the end of the
12 weeks of the study will continue to be treated until closed based on the decision of the
Altru Wound Care Clinic providers. Complete wound closure will be defined as 100%
re-epithelization without drainage or infection. Subjects clinic charts/records will be
reviewed by the researchers to collect the following data: group assigned to, gender, age,
diabetes diagnosis, co-morbidities, time ulcer has been present, if conventional treatment
occurred for two weeks, date of 1st wound clinic visit, last HbA1c, date ulcer 1st noticed
by patient, depth, and size of ulcer, ankle-brachial index, and ulcer characteristics at
each visit will also be documented. At the conclusion of the study, subjects will complete a
12 question satisfaction questionnaire and six demographic questions on the TCC-EZ which
will be administered by the clinic nurse or provider. Subjects may elect to withdraw from
the study at any time without repercussion.

Inclusion Criteria:

- 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 > 1.0cm2 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.-

Exclusion Criteria:

- 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.
We found this trial at
1
site
860 South Columbia Road
Grand Forks, North Dakota 58201
701-780-1750
?
mi
from
Grand Forks, ND
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