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Trial record 8 of 439 for:    Foot Diseases | "Diabetic Foot"

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

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ClinicalTrials.gov Identifier: NCT02209051
Recruitment Status : Completed
First Posted : August 5, 2014
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation

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

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Other: AMNIOEXCEL Other: Standard of Care, Diabetic Foot Ulcers Not Applicable

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  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Measures :
  1. Time to complete wound closure of the target ulcer [ Time Frame: 8 weeks ]
  2. Rate of wound closure [ Time Frame: 8 Weeks ]
  3. Incidence, severity and type of adverse events [ Time Frame: 8 Weeks ]
    This outcome measure represents a composite of collected adverse event data.

  4. Changes in Quality of Life assessment [ Time Frame: 8 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209051


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT02209051     History of Changes
Other Study ID Numbers: DS2014.01.01
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017

Keywords provided by Integra LifeSciences Corporation:
Diabetic Foot Ulcers
Wagner Grade 1 or 2 foot ulcers
Foot health
Foot Ulcer
Diabetic Foot
Foot Diseases
Skin Diseases
Vascular Diseases
Cardiovascular Diseases
Endocrine System Diseases
AMNIOEXCEL
Wound
Ulcer
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Diabetes Complications
Diabetes Mellitus
Diabetic Neuropathies

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Vascular Diseases
Cardiovascular Diseases
Skin Diseases
Endocrine System Diseases
Foot Diseases
Ulcer
Pathologic Processes
Diabetic Angiopathies
Leg Ulcer
Skin Ulcer
Diabetes Complications
Diabetes Mellitus
Diabetic Neuropathies