miR-200b & miR-21 in Diabetic Wounds

Completed

Conditions studied: Diabetes Mellitus, Foot Ulcer, Ulcer, Diabetic Foot Ulcer, Wound, Wound Heal

In brief

This study aims to determine if elevated wound-edge endothelial miR-200b is a barrier to wound healing in diabetic patients and also to determine if ex vivo supplementation of miR-21 mimic and recombinant MFG-E8 resolve inflammation in wound macrophages isolated from NPWT sponges from diabetic wounds. This study will enroll 124 (60 in the miR-200b arm and 64 in the miR21 arm) Diabetic Wound patients who have wound tissue oxygenation adequate to support wound healing and will be in the study for 14 weeks that includes 4 study visits.

Key facts

Study ID

NCT02581098

Run by

Indiana University

People needed

98

Starts

2015-08-01

Expected to finish

2023-06-26

Last updated by the study team

2024-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 18 and older
• Willing and able to provide informed consent
• Willing and able to comply with protocol instructions, including all biopsies and study visits
• Diabetes Mellitus
• Chronic wounds (open >30d) of any etiology
• Subjects with Negative Pressure Wound Therapy (NPWT or also called a wound vac) (Note: Applies only to the miR-21 arm)

You may not qualify if…

• Revascularization surgery on the target wound within 60 days prior to enrollment
• Inadequate arterial supply, as evidenced by any of the following:
• Transcutaneous Oxygen Measurement (TcOM) < 30mmg
• Ankle Brachial Index (ABI) <0.7 or 1.3
• Toe Brachial Index (TBI) <0.6
• Subjects with marked immunodeficiency (HIV/AIDS, organ transplant patients and actively being treated for cancer)
• Trauma wounds
• Wounds closed or to be closed by flap or graft coverage
• Women who are pregnant

Where it is running

• IU Health Methodist Hospital — Indianapolis, Indiana, United States
• OSU Hospital East — Columbus, Ohio, United States
• Davis Heart and Lung Research Institute — Columbus, Ohio, United States
• Martha Morehouse Medical Plaza — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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