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

Diabetic Foot Ulcers Clinical Trial

Official title:

A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02844660
• Other study ID #: ECDFU001
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 2018

Study information

• Verified date: November 2020
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject has a known history of Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).

2. Index ulcer characteristics:

a. Ulcer present for = 30 days prior to randomization (Day 0) b. Index ulcer is located below the ankle c. Index ulcer area after debridement is = 1 cm² and = 15 cm² at the randomization visit 3. Subject has completed 14-day run-in period with = 30% wound area reduction post-debridement.

4. Subject has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:

• Dorsum transcutaneous oxygen test (TcPO2) with results = 30 mmHg, OR

• ABIs with results of = 0.7 and = 1.2, OR

• Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot 5. Age = 18 6. The subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study

1. Index Ulcer Assessment:

1. Penetrates down totendon, or bone

2. Presence of another diabetic foot ulcer within 3 cm of the index ulcer

3. Index ulcer determined to be due to active Charcot deformity or major structural abnormalities of the foot

4. Exhibits clinical signs and symptoms of infection

5. Known or suspected local skin malignancy to the index diabetic ulcer

6. Wound duration > one year without intermittent closure

2. Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:

1. In the last 7 days - Negative pressure wound therapy (wound vac or SNaP®) of the index ulcer

2. In the last 7 days - Hyperbaric oxygen (HBO) therapy

3. In the last 10 days - Chemical debridement, Dakin's solution, medical honey therapy

4. In the last 30 days - Treatment with cytotoxic chemotherapy, application of topical steroids to the ulcer surface, or use of = 14 days of immune-suppressants (including systemic corticosteroids); or, subject is anticipated to require such medications during the course of the study

5. In the last 30 days - study ulcer treatment with any biological skin substitutes, including EpiCord, biomedical or topical growth factors, tissue engineered materials (e.g. Apligraf® or Dermagraft®), or other scaffold materials (e.g. OASIS® Wound Matrix, MatriStem® Wound Matrix, Grafix, etc.)

6. In the last 30 days - Subject has been on any investigational drug(s) or therapeutic device(s)

7. In the last 6 months - Amputation or revascularization (surgical or stenting) to the affected leg or foot

3. Subject criteria that will make subject ineligible for enrollment:

1. Known osteomyelitis or active cellulitis at wound site

2. Hemoglobin A1C >12 in the last 60 days prior to randomization

3. History of Immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or HIV

4. Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate

5. Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator

6. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)

7. Known history of poor compliance with medical treatments

8. Subjects currently enrolled in this study. Concurrent enrollment in the study is prohibited

9. Subjects currently receiving radiation therapy or chemotherapy

10. Patients currently on dialysis or planning to start dialysis

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Biological:
• EpiCord
Weekly application of EpiCord and standard of care (moist wound therapy and offloading)

Other:
• Standard of Care
moist wound therapy and offloading

Locations

Country	Name	City	State
United States	Joseph M. Still Burn Center at Doctors Hospital	Augusta	Georgia
United States	Central Research Associates	Birmingham	Alabama
United States	ILD Research	Carlsbad	California
United States	Limb Preservation Platform, Inc	Fresno	California
United States	Ambulatory Foot & Ankle Center, PC	Hampton	Virginia
United States	Foot and Ankle Center	Haverford	Pennsylvania
United States	Advanced Foot & Ankle Center	Las Vegas	Nevada
United States	Foot and ankle clinic	Los Angeles	California
United States	Futuro Clinical Trials	McAllen	Texas
United States	Doctors Research Network	Miami	Florida
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Arizona Regional Medical Research (ARMR)	Tucson	Arizona
United States	Costal Podiatry	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Ulcer Closure	The percentage of subjects with complete closure of the study ulcer as assessed by photographic evaluation	12 weeks
Primary	Study Safety Measurement	The proportion of product related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 12 weeks.	12 weeks
Secondary	Time to complete closure	As assessed by photographic evaluation and the Investigator	up to 12 weeks
Secondary	Rate of wound closure	As assessed by photographic evaluation and the Investigator	up to 12 weeks
Secondary	Incidence of ulcer recurrence	Incidence of ulcer recurrence at the site of the study ulcer	up to 12 weeks
Secondary	Quality of Life Health Survey	Change in quality of life metrics as measured by SF-36 Health Survey	up to 12 weeks
Secondary	Quality of Life-Pain	Change in quality of life metrics as measured by changes in the patients reported pain scores as measure by the Visual Analog Scale	up to 12 weeks
Secondary	Cost effectiveness of treatment	Cost effectiveness of treatment regime. looking at the number of grafts used on each study subject throughout the study.	up to 12 weeks