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

Diabetic Foot Ulcer Clinical Trial

— DOLCE  

Official title:

A Comparative Efficacy Study: Treatments of Non-Healing Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450943
• Other study ID #: SURG-005-10S
• Secondary ID: 11-04-00618
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2011
• Est. completion date: April 4, 2018

Study information

• Verified date: August 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 4, 2018
• Est. primary completion date: December 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Device:
• SECONDARY dressing gauze and tape
SECONDARY dressing gauze and tape

Procedure:
• debridement, irrigation
debridement, irrigation

Device:
• Dermagraft
Dermagraft per company protocol
• Oasis
Oasis per company protocol

Locations

Country	Name	City	State
United States	VA Northern California Health Care System, Mather, CA	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	VA Northern California Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Closure by Week 15	The primary outcome of interest is defined as the wound healed completely on or before visit 15, regardless of a later recurrence.	15 weeks
Secondary	Wound Closure at 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.	20 weeks
Secondary	Cost Effectiveness		12 weeks