Preventing Diabetic Foot Ulcers Through Cleaner Feet

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Foot complications are among the most serious and costly complications of diabetes. People with diabetes have a 10-fold increased risk for a leg or foot amputation compared to those that do not have diabetes. Amputation of all or part of foot is usually preceded by a foot ulcer, which became infected. This is a clinical trial to test the effectiveness of a topical antiseptic, chlorhexidine, for daily foot cleaning on the recurrence of diabetic foot ulcers in Veterans with a recent history of a foot ulcer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Chlorhexidine; Chlorhexidine gluconate

Criteria

Inclusion Criteria:

• Adults >=18 years

• Clinical diagnosis of diabetes

• At high risk for a new diabetic foot ulcer due to: 1)Past history of diabetic foot ulcer or 2)Past history of major foot surgery including partial foot amputation or 3)Past history of major foot infection or 4)Neuropathy and onychomycosis and hemoglobin A1C >8% or 5)Neuropathy and peripheral vascular disease or 6)Dialysis or 7)Past history of Charcot foot or 8)Past history of peripheral vascular surgery or angiography with stent

• Two feet (can have amputation of part of the foot)

• At least one foot without a foot ulcer

• Permanent mailing address suitable for provision of specimen collection materials and telephone suitable for monthly follow-up

• Able to give written informed consent

Exclusion Criteria:

• Amputation of the foot planned to treat current foot ulcer or wound

• Current foot infection

• Use of topical chlorhexidine on feet 7 days prior to randomization

• History of an allergic reaction to chlorhexidine

• Unable to use wipes for foot care

• Inability to walk

• Life expectancy less than 12 months

• Plans to move out of the area in the next 13 months

• Requires equivalent of institutional care (e.g. nursing home)

• Any other criteria which, in the investigator's opinion, would compromise the safety of the study, the ability of a subject to participate, or the results of the study