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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01450943
First Posted: October 13, 2011
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
VA Northern California Health Care System
Information provided by (Responsible Party):
VA Office of Research and Development
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparative Efficacy Study: Treatments of Non-Healing Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Wound closure by week 12 [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Wound closure at 20 weeks [ Time Frame: 20 weeks ]
  • Cost effectiveness [ Time Frame: 12 weeks ]

Estimated Enrollment: 171
Actual Study Start Date: October 1, 2011
Estimated Study Completion Date: November 1, 2017
Primary Completion Date: April 1, 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%.
  Contacts and Locations
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): NCT01450943


Locations
United States, California
VA Northern California Health Care System, Mather, CA
Sacramento, California, United States, 95655
Sponsors and Collaborators
VA Office of Research and Development
VA Northern California Health Care System
Investigators
Principal Investigator: Rivkah R. Isseroff VA Northern California Health Care System, Mather, CA
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01450943     History of Changes
Other Study ID Numbers: SURG-005-10S
11-04-00618 ( Other Grant/Funding Number: VA Northern California Health Care System )
First Submitted: October 7, 2011
First Posted: October 13, 2011
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by VA Office of Research and Development:
Diabetic Foot Ulcer
Chronic wounds
Chronic ulcers
Oasis
Dermagraft
Adaptic

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