Clinical trial NCT02844660: Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers
Official title: A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcers
Keywords: Diabetes Mellitus
Foot Diseases
Foot Ulcer
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-26
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete Ulcer Closure
timeFrame: 12 weeks
measure: Study Safety Measurement
timeFrame: 12 weeks
Secondary outcomes:
measure: Time to complete closure
timeFrame: up to 12 weeks
measure: Rate of wound closure
timeFrame: up to 12 weeks
measure: Incidence of ulcer recurrence
timeFrame: up to 12 weeks
measure: Quality of Life Health Survey
timeFrame: up to 12 weeks
measure: Quality of Life-Pain
timeFrame: up to 12 weeks
measure: Cost effectiveness of treatment
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates
state: Alabama
city: Tucson
country: United States
facility: Arizona Regional Medical Research (ARMR)
state: Arizona
city: Carlsbad
country: United States
facility: ILD Research
state: California
city: Fresno
country: United States
facility: Limb Preservation Platform, Inc
state: California
city: Los Angeles
country: United States
facility: Foot and ankle clinic
state: California
city: Miami
country: United States
facility: Doctors Research Network
state: Florida
city: Augusta
country: United States
facility: Joseph M. Still Burn Center at Doctors Hospital
state: Georgia
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Las Vegas
country: United States
facility: Advanced Foot & Ankle Center
state: Nevada
city: Haverford
country: United States
facility: Foot and Ankle Center
state: Pennsylvania
city: McAllen
country: United States
facility: Futuro Clinical Trials
state: Texas
city: Hampton
country: United States
facility: Ambulatory Foot & Ankle Center, PC
state: Virginia
city: Virginia Beach
country: United States
facility: Costal Podiatry
state: Virginia
Study officials:
affiliation: Intermountain Medical Center
name: William Tettelbach, MD
role: PRINCIPAL_INVESTIGATOR
References: