Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers

A Multicenter, Prospective, Randomized, Parallel-group, Standard of Care-controlled Clinical Trial to Evaluate the Use of AMNIOEXCEL® in the Management of Chronic Diabetic Foot Ulcers

The primary goal of the study is to demonstrate the increased rate of complete wound closure by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Other: AMNIOEXCEL; Other: Standard of Care, Diabetic Foot Ulcers

Detailed Description

Potential study candidates will be Screened for Inclusion and Exclusion criteria after providing informed consent. Candidates will have their wound cleansed and debrided (if necessary), photographed and measured. Blood will be drawn for laboratory analyses. Patients will return two weeks later for assessment.

Upon return, per the original protocol, patient would have been randomized at <20% closure; per Amendment 1, if the wound has closed <30% in area during the 2 week Screening Period and all other eligibility criteria are met, the patient will be randomized (1:1) to receive either AMNIOEXCEL® with Standard of Care (SOC) or SOC alone.

All patients enrolled in this study will receive SOC. For the purposes of this study, Standard of Care (SOC) includes debridement of necrotic/non-viable tissue, moist wound dressings, off-loading (where appropriate, DH Walker only) and infection surveillance and management. For those randomized to receive AMNIOEXCEL®, in addition to SOC, the tissue will be applied after the wound has been debrided and hemostasis achieved. The wound will then be dressed with a non-adherent dressing (e.g. Adaptic) and covered with a moisture retentive dressing.

The patient will return once weekly for wound care, photographs and ulcer measurement. At each visit, the wound will be assessed and AMNIOEXCEL® reapplied as appropriate, based upon physician judgment. All patients complete their participation at Week 6.

This is an open label study and no attempt will be made to blind subjects or Investigators to randomization allocation.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Associated Foot and Ankle Specialists, LLC
  • California
    • Castro Valley, California, United States, 94546
      • Center for Clinical Research, Inc.
    • Stockton, California, United States, 95204
      • Pacific Wound Center
  • Florida
    • Jacksonville, Florida, United States, 32216
      • First Coast Cardiovascular Institute
    • North Miami Beach, Florida, United States, 33169
      • Barry University Clinical Research
  • Massachusetts
    • Plymouth, Massachusetts, United States, 02360
      • Beth Israel Deaconess Hospital - Plymouth
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Goldsboro, North Carolina, United States, 27533
      • Wayne Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. an ambulatory person at least 18 years of age at the time of informed consent.
2. type 1 or type 2 diabetes mellitus.
3. glycosylated hemoglobin (HbA1c) of ≤12%

4. at least one wound that is/has:

   • Wagner grade 1 or superficial 2 (without bone, tendon or joint exposure),
   • duration of at least 1 month,
   • no clinical signs of infection or osteomyelitis,
   • between 1cm2 and 25cm2 in area,
   • per original protocol, closed <20% in area during the Screening Period; per Amendment #1, closed <30% in area during Screening and
   • located on the foot, distal to malleoli.
5. adequate circulation to the affected extremity
6. serum creatinine of <3.0mg/dl.

Exclusion Criteria:

1. participated in another clinical trial within 30 days prior to consent,
2. Active Charcot deformity of the study foot (i.e. erythematous, warm, edematous and actively remodeling)
3. receiving radiation or chemotherapy of any kind,
4. known or suspected malignancy of current ulcer,
5. pregnant or breast feeding,
6. an active malignant disease,
7. receiving hemo- or peritoneal dialysis,
8. sickle cell anemia or Raynaud's syndrome,
9. diagnosis of autoimmune connective tissue disease,
10. received a biologic agent, growth factor, xenograft or skin equivalent in the 30 days prior to consent,
11. exposed bone, tendon or joint capsule in the study ulcer,
12. currently receiving antibiotics (for any reason), or
13. taking medications considered to be immune system modulators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AMNIOEXCEL; Human Amniotic Membrane Allograft	Other: AMNIOEXCEL; Application of AMNIOEXCEL every 1-2 weeks for a period of 6 weeks or until wound closure, whichever is sooner.; Other: Standard of Care, Diabetic Foot Ulcers; Advanced wound care dressings and offloading applied daily for a period of 8 weeks or until wound closure
Active Comparator: Standard of Care, Diabetic Foot Ulcers; Advanced wound care dressings and offloading of wound.	Other: Standard of Care, Diabetic Foot Ulcers; Advanced wound care dressings and offloading applied daily for a period of 8 weeks or until wound closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with complete wound closure (i.e. complete skin re-epithelialization without drainage or dressing requirements) at 6 weeks after initiation of study treatment	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete wound closure of the target ulcer		8 weeks
Rate of wound closure		8 Weeks
Incidence, severity and type of adverse events	This outcome measure represents a composite of collected adverse event data.	8 Weeks
Changes in Quality of Life assessment		8 Weeks

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation

Publications and helpful links

General Publications

• Snyder RJ, Shimozaki K, Tallis A, Kerzner M, Reyzelman A, Lintzeris D, Bell D, Rutan RL, Rosenblum B. A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer. Wounds. 2016 Mar;28(3):70-7.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: August 4, 2014
• First Posted (Estimate): August 5, 2014

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: November 30, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Foot Ulcers; Diabetes Complications; Diabetic Angiopathies; Wound; Endocrine System Diseases; Skin Diseases; Leg Ulcer; Ulcer; Skin Ulcer; Foot Diseases; Foot Ulcer; Diabetic Foot; Diabetic Neuropathies; Foot health; Wagner Grade 1 or 2 foot ulcers; AMNIOEXCEL
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: DS2014.01.01