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

VA Office of Research and Development

Status and phase: Completed; Phase 3

Conditions: Diabetic Foot Ulcer

Treatments: Device: Oasis; Procedure: debridement, irrigation; Device: Dermagraft; Device: SECONDARY dressing gauze and tape

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01450943

SURG-005-10S

11-04-00618 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Standard of care

Active Comparator group

Description:

debridement, irrigation , PRIMARY dressing Adaptic and Iodosorb, SECONDARY dressing gauze and tape

Treatment:

Procedure: debridement, irrigation

Device: SECONDARY dressing gauze and tape

Dermagraft

Experimental group

Description:

debridement, irrigation , PRIMARY dressing Dermagraft and Adaptic, SECONDARY dressing gauze and tape

Treatment:

Procedure: debridement, irrigation

Device: Dermagraft

Device: SECONDARY dressing gauze and tape

Oasis

Experimental group

Description:

debridement, irrigation , PRIMARY dressing Oasis and Adaptic, SECONDARY dressing gauze and tape

Treatment:

Procedure: debridement, irrigation

Device: Oasis

Device: SECONDARY dressing gauze and tape