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VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic (DOLCE)

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ClinicalTrials.gov Identifier: NCT01450943
Recruitment Status : Completed
First Posted : October 13, 2011
Results First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
VA Northern California Health Care System
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE October 7, 2011
First Posted Date  ICMJE October 13, 2011
Results First Submitted Date  ICMJE July 31, 2019
Results First Posted Date  ICMJE September 17, 2019
Last Update Posted Date September 17, 2019
Actual Study Start Date  ICMJE October 1, 2011
Actual Primary Completion Date December 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
Wound Closure by Week 15 [ Time Frame: 15 weeks ]
The primary outcome of interest is defined as the wound healed completely on or before visit 15, regardless of a later recurrence.
Original Primary Outcome Measures  ICMJE
 (submitted: October 12, 2011)
Wound closure by week 12 [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT01450943 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
  • Wound Closure at 20 Weeks [ Time Frame: 20 weeks ]
    Complete wound closure at study endpoint. The Secondary outcome of interest is defined as the wound healed completely on or before visit 19, regardless of a later recurrence. The number of subjects analyzed at secondary outcome differs from primary outcome due to some subjects not completing the study.
  • Cost Effectiveness [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2011)
  • Wound Closure at 20 Weeks [ Time Frame: 20 weeks ]
  • Cost Effectiveness [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic
Official Title  ICMJE A Comparative Efficacy Study: Treatments of Non-Healing Diabetic Foot Ulcers
Brief Summary The primary objective of this study is to assess the effectiveness of cellular dermal replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that these devices are of equal efficacy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot Ulcer
Intervention  ICMJE
  • Device: SECONDARY dressing gauze and tape
    SECONDARY dressing gauze and tape
  • Procedure: debridement, irrigation
    debridement, irrigation
  • Device: Dermagraft
    Dermagraft per company protocol
  • Device: Oasis
    Oasis per company protocol
Study Arms  ICMJE
  • Active Comparator: Standard of care
    debridement, irrigation , PRIMARY dressing Adaptic and Iodosorb, SECONDARY dressing gauze and tape
    Interventions:
    • Device: SECONDARY dressing gauze and tape
    • Procedure: debridement, irrigation
  • Experimental: Dermagraft
    debridement, irrigation , PRIMARY dressing Dermagraft and Adaptic, SECONDARY dressing gauze and tape
    Interventions:
    • Device: SECONDARY dressing gauze and tape
    • Procedure: debridement, irrigation
    • Device: Dermagraft
  • Experimental: Oasis
    debridement, irrigation , PRIMARY dressing Oasis and Adaptic, SECONDARY dressing gauze and tape
    Interventions:
    • Device: SECONDARY dressing gauze and tape
    • Procedure: debridement, irrigation
    • Device: Oasis
Publications * Lev-Tov H, Li CS, Dahle S, Isseroff RR. Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial. Trials. 2013 Jan 9;14:8. doi: 10.1186/1745-6215-14-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2019)
120
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2011)
171
Actual Study Completion Date  ICMJE April 4, 2018
Actual Primary Completion Date December 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

(Answering NO will exclude patient):

  • An Institutional Review Board (IRB) Informed Consent Form signed and dated prior to any study-related activities.
  • The area of the study ulcer after debridement is between 1 cm2 and 25 cm2 at Visit 3/Week 0.
  • Subjects between 18 and 85 years of age.
  • Subject's highest Ankle-Brachial Pressure Index (ABPI) / Ankle-Arm Index (AAI) is greater than or equal to 0.80 and lower than 1.4 (the highest ABPI/AAI value from three measurements within last 6 months shall apply).or a toe-arm index is equal to or higher than 0.6.
  • The patient has one or more diabetic ulcers on the target foot with only one ulcer selected as the study (target) ulcer. The target ulcer must be at least 4 cm from a non-target ulcer and in the Investigator's opinion, be unlikely to coalesce with another ulcer within 12 weeks of randomization.
  • Subject's study ulcer is full thickness and does not extend to bone, muscle, or tendon.
  • Subject's study ulcer has been present at least 4 weeks prior to the initial screening (Visit 1) or 6 weeks at randomization (Visit 3).
  • Subject has been diagnosed with Type 1 or Type 2 diabetes and HbA1c is less than 10%.
  • Study ulcer has no clinical feature of infection (2 signs of inflammation and elevated bacterial load of the wound).
  • For female subjects of childbearing age potential, the subject has a negative pregnancy test and is not lactating for the duration of the study.
  • Subject understands the requirements of this study and is willing to comply with all the study requirements.

Exclusion Criteria:

(Answering YES will exclude patient):

  • The subject is diagnosed with cancer and is undergoing treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment.
  • The subject is diagnosed with HIV/AIDS.
  • The subject is diagnosed with any bleeding disorders.
  • The subject is diagnosed with any connective tissue diseases.
  • For female subjects, the subject is pregnant or lactating.
  • The subject has a history of illicit drug use within one year of enrollment.
  • In the past year, the subject experiences episodes of drinking more than 5 alcoholic beverages in less than two hours and/or drinking alcohol has become a problem in interpersonal relationships, work, driving and/or their behavior in general.
  • The subject has any active infected wounds or osteomyelitis (confirmed by bone biopsy, MRI or bone scan).
  • Doppler exam within the last 365 days demonstrating reflux greater than 0.5 seconds.
  • The subject is diagnosed with active Charcot as described by Saunder's classification system.
  • The subject manifests signs of poor nutritional status and/or albumin level < 2.9.
  • The subject has been exposed to Dermagraft and/or Oasis in the last 60 days.
  • The study ulcer size is less than 0.5 cm2 or greater than 25 cm2.
  • The subject has any porcine allergy or cow product allergy.
  • The subject's recent (last 30 days) chemistry tests serum creatinine is 2 times above the upper limit of normal and/or LFT's 3 times above the upper limit of normal.
  • Between Visit 1/Week -2 and Visit 3/Week 0 (randomization) the study ulcer has decreased in size by more than 40%, or increased in size by more than 50%.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01450943
Other Study ID Numbers  ICMJE SURG-005-10S
11-04-00618 ( Other Grant/Funding Number: VA Northern California Health Care System )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE VA Northern California Health Care System
Investigators  ICMJE
Principal Investigator: Rivkah R. Isseroff, MD VA Northern California Health Care System, Mather, CA
PRS Account VA Office of Research and Development
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP