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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by VA Northern California Health Care System
Sponsor:
Information provided by (Responsible Party):
VA Northern California Health Care System
ClinicalTrials.gov Identifier:
NCT01450943
First received: October 7, 2011
Last updated: June 18, 2014
Last verified: June 2014

October 7, 2011
June 18, 2014
October 2011
October 2016   (final data collection date for primary outcome measure)
Wound closure by week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01450943 on ClinicalTrials.gov Archive Site
  • Wound closure at 20 weeks [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Cost effectiveness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic Foot Ulcers
A Comparative Efficacy Study: Treatment of Non-Healing Diabetic Foot

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Foot Ulcer
  • 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
  • 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™
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.
 
Recruiting
171
Not Provided
October 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

(Answering NO will exclude patient):

  1. An Institutional Review Board (IRB) Informed Consent Form signed and dated prior to any study-related activities.
  2. The area of the study ulcer after debridement is between 1 cm2 and 25 cm2 at Visit 3/Week 0.
  3. Subjects between 18 and 85 years of age.
  4. 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.
  5. 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.
  6. Subject's study ulcer is full thickness and does not extend to bone, muscle, or tendon.
  7. 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).
  8. Subject has been diagnosed with Type 1 or Type 2 diabetes and HbA1c is less than 10%.
  9. Study ulcer has no clinical feature of infection (2 signs of inflammation and elevated bacterial load of the wound).
  10. For female subjects of childbearing age potential, the subject has a negative pregnancy test and is not lactating for the duration of the study.
  11. Subject understands the requirements of this study and is willing to comply with all the study requirements.

Exclusion Criteria:

(Answering YES will exclude patient):

  1. 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.
  2. The subject is diagnosed with HIV/AIDS.
  3. The subject is diagnosed with any bleeding disorders.
  4. The subject is diagnosed with any connective tissue diseases.
  5. For female subjects, the subject is pregnant or lactating.
  6. The subject has a history of illicit drug use within one year of enrollment.
  7. 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.
  8. The subject has any active infected wounds or osteomyelitis (confirmed by bone biopsy, MRI or bone scan).
  9. Doppler exam within the last 365 days demonstrating reflux greater than 0.5 seconds.
  10. The subject is diagnosed with active Charcot as described by Saunder's classification system.
  11. The subject manifests signs of poor nutritional status and/or albumin level < 2.9.
  12. The subject has been exposed to Dermagraft® and/or Oasis® in the last 60 days.
  13. The study ulcer size is less than 0.5 cm2 or greater than 25 cm2.
  14. The subject has any porcine allergy or cow product allergy.
  15. 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.
  16. 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%.
Both
18 Years to 85 Years
No
Contact: Catherine Tchanque-Fossuo, M.D. tchanquec@gmail.com
Contact: Lam Nguyen 916-734-6556 lam.nguyen@ucdmc.ucdavis.edu
United States
 
NCT01450943
11-04-00618
No
VA Northern California Health Care System
VA Northern California Health Care System
Not Provided
Principal Investigator: Roslyn Isseroff, M.D. VA Northern California Health Care System
VA Northern California Health Care System
June 2014

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