VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic (DOLCE)
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ClinicalTrials.gov Identifier: NCT01450943 |
Recruitment Status :
Completed
First Posted : October 13, 2011
Results First Posted : September 17, 2019
Last Update Posted : September 17, 2019
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Sponsor:
VA Office of Research and Development
Collaborator:
VA Northern California Health Care System
Information provided by (Responsible Party):
VA Office of Research and Development
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Diabetic Foot Ulcer |
Interventions |
Device: SECONDARY dressing gauze and tape Procedure: debridement, irrigation Device: Dermagraft Device: Oasis |
Enrollment | 120 |
Participant Flow
Recruitment Details | 120 subjects enrolled from which 2 study subjects were not randomized into any groups and were terminated from the study; therefore, we only had overall of 118 study subjects. |
Pre-assignment Details |
Baseline Characteristics
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Sara Dahle, D.P.M., M.P.H. |
Organization: | VA Northern California Health Care System |
Phone: | 916-843-7151 |
EMail: | Sara.dahle@va.gov |
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 |
Results First Submitted: | July 31, 2019 |
Results First Posted: | September 17, 2019 |
Last Update Posted: | September 17, 2019 |