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

Primary Purpose

Diabetic Foot Ulcers

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AMNIOEXCEL
Standard of Care, Diabetic Foot Ulcers
Sponsored by
Integra LifeSciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcers focused on measuring Diabetic Foot Ulcers, AMNIOEXCEL, Wagner Grade 1 or 2 foot ulcers, Wound, Foot health, Ulcer, Foot Ulcer, Diabetic Foot, Foot Diseases, Skin Diseases, Leg Ulcer, Skin Ulcer, Diabetic Angiopathies, Vascular Diseases, Cardiovascular Diseases, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases, Diabetic Neuropathies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Associated Foot and Ankle Specialists, LLC
  • Center for Clinical Research, Inc.
  • Pacific Wound Center
  • First Coast Cardiovascular Institute
  • Barry University Clinical Research
  • Beth Israel Deaconess Hospital - Plymouth
  • Duke University
  • Wayne Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AMNIOEXCEL

Standard of Care, Diabetic Foot Ulcers

Arm Description

Human Amniotic Membrane Allograft

Advanced wound care dressings and offloading of wound.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 31, 2014
Last Updated
November 30, 2017
Sponsor
Integra LifeSciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02209051
Brief Title
Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integra LifeSciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
Keywords
Diabetic Foot Ulcers, AMNIOEXCEL, Wagner Grade 1 or 2 foot ulcers, Wound, Foot health, Ulcer, Foot Ulcer, Diabetic Foot, Foot Diseases, Skin Diseases, Leg Ulcer, Skin Ulcer, Diabetic Angiopathies, Vascular Diseases, Cardiovascular Diseases, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases, Diabetic Neuropathies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMNIOEXCEL
Arm Type
Active Comparator
Arm Description
Human Amniotic Membrane Allograft
Arm Title
Standard of Care, Diabetic Foot Ulcers
Arm Type
Active Comparator
Arm Description
Advanced wound care dressings and offloading of wound.
Intervention Type
Other
Intervention Name(s)
AMNIOEXCEL
Intervention Description
Application of AMNIOEXCEL every 1-2 weeks for a period of 6 weeks or until wound closure, whichever is sooner.
Intervention Type
Other
Intervention Name(s)
Standard of Care, Diabetic Foot Ulcers
Intervention Description
Advanced wound care dressings and offloading applied daily for a period of 8 weeks or until wound closure
Primary Outcome Measure Information:
Title
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Time to complete wound closure of the target ulcer
Time Frame
8 weeks
Title
Rate of wound closure
Time Frame
8 Weeks
Title
Incidence, severity and type of adverse events
Description
This outcome measure represents a composite of collected adverse event data.
Time Frame
8 Weeks
Title
Changes in Quality of Life assessment
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: an ambulatory person at least 18 years of age at the time of informed consent. type 1 or type 2 diabetes mellitus. glycosylated hemoglobin (HbA1c) of ≤12% 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. adequate circulation to the affected extremity serum creatinine of <3.0mg/dl. Exclusion Criteria: participated in another clinical trial within 30 days prior to consent, Active Charcot deformity of the study foot (i.e. erythematous, warm, edematous and actively remodeling) receiving radiation or chemotherapy of any kind, known or suspected malignancy of current ulcer, pregnant or breast feeding, an active malignant disease, receiving hemo- or peritoneal dialysis, sickle cell anemia or Raynaud's syndrome, diagnosis of autoimmune connective tissue disease, received a biologic agent, growth factor, xenograft or skin equivalent in the 30 days prior to consent, exposed bone, tendon or joint capsule in the study ulcer, currently receiving antibiotics (for any reason), or taking medications considered to be immune system modulators.
Facility Information:
Facility Name
Associated Foot and Ankle Specialists, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Center for Clinical Research, Inc.
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Pacific Wound Center
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
First Coast Cardiovascular Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Barry University Clinical Research
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Beth Israel Deaconess Hospital - Plymouth
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wayne Memorial Hospital
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27533
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26978860
Citation
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.
Results Reference
derived

Learn more about this trial

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

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