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
  Purpose

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.


Condition Intervention
Diabetic Foot Ulcer
Device: SECONDARY dressing gauze and tape
Procedure: debridement, irrigation
Device: Dermagraft™
Device: Oasis™

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic Foot

Resource links provided by NLM:


Further study details as provided by VA Northern California Health Care System:

Primary Outcome Measures:
  • Wound closure by week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 171
Study Start Date: October 2011
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of care
debridement, irrigation , PRIMARY dressing Adaptic® and Iodosorb, SECONDARY dressing gauze and tape
Device: SECONDARY dressing gauze and tape
SECONDARY dressing gauze and tape
Procedure: debridement, irrigation
debridement, irrigation
Experimental: Dermagraft™
debridement, irrigation , PRIMARY dressing Dermagraft™ and Adaptic®, SECONDARY dressing gauze and tape
Device: SECONDARY dressing gauze and tape
SECONDARY dressing gauze and tape
Procedure: debridement, irrigation
debridement, irrigation
Device: Dermagraft™
Dermagraft™ per company protocol
Experimental: Oasis™
debridement, irrigation , PRIMARY dressing Oasis™ and Adaptic®, SECONDARY dressing gauze and tape
Device: SECONDARY dressing gauze and tape
SECONDARY dressing gauze and tape
Procedure: debridement, irrigation
debridement, irrigation
Device: Oasis™
Oasis™ per company protocol

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450943

Contacts
Contact: Catherine Tchanque-Fossuo, M.D. tchanquec@gmail.com
Contact: Lam Nguyen 916-734-6556 lam.nguyen@ucdmc.ucdavis.edu

Locations
United States, California
Sacramento VA Medical Center Recruiting
Mather, California, United States, 95655
Contact: Catherine Tchanque-Fossuo, M.D.    916-734-6556    tchanquec@gmail.com   
Contact: Lam Nguyen         
Principal Investigator: Roslyn Isseroff, M.D.         
Sponsors and Collaborators
VA Northern California Health Care System
Investigators
Principal Investigator: Roslyn Isseroff, M.D. VA Northern California Health Care System
  More Information

No publications provided by VA Northern California Health Care System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VA Northern California Health Care System
ClinicalTrials.gov Identifier: NCT01450943     History of Changes
Other Study ID Numbers: 11-04-00618
Study First Received: October 7, 2011
Last Updated: June 18, 2014
Health Authority: United States: Federal Government

Keywords provided by VA Northern California Health Care System:
Diabetic Foot Ulcer
Chronic wounds
Chronic ulcers
Oasis
Dermagraft
Adaptic

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

ClinicalTrials.gov processed this record on August 26, 2014