Clinical trial NCT03503370: Preventing Diabetic Foot Ulcers Through Cleaner Feet
Official title: Preventing Diabetic Foot Ulcers Through Manipulating the Skin Microbiota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Foot Ulcer
Keywords: topical chlorhexidine
prevention
clinical trial
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-04-19
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single center, randomized, double blind (participant, outcome assessor), parallel group clinical trial comparing daily foot care with cloths containing 2% chlorhexidine compared to daily foot care with cloths not containing chlorhexidine.
Primary purpose: PREVENTION

Brief 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 occurrence of diabetic foot ulcers in Veterans at high risk of a diabetic foot ulcer.

Detailed description: Population: Up to 200 Veterans at high risk of a diabetic foot ulcer

Site: VA Maryland Health Care System (VAMHCS)

Study Duration: Approximately 5 years

Study Design: Randomized double-blind clinical trial comparing a) a daily foot care regimen with cloths containing 2% chlorhexidine to b) a daily foot care regimen with cloths not containing 2% chlorhexidine

Objectives:

Primary: To determine if chlorhexidine reduces the occurrence of foot complications including chronic foot ulcer, foot infection or foot amputation.

Secondary: To determine if chlorhexidine increases antibiotic resistance among bacterial pathogens on feet.

Exploratory: To describe changes in the microbiota of the feet with chlorhexidine and foot complications

Treatment Regimens: 2% Chlorhexidine Gluconate Cloths versus Bath Cloths

Route of Administration: Topical application on the feet

Dose and Interval: 1 cloth daily

Duration of Participant's Participation: Up to 13 months

Eligibility 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

Primary outcomes:
measure: Time to New Foot Complication Among All Randomized Participants
timeFrame: 12 months
Secondary outcomes:
measure: Susceptibility to Chlorhexidine Among Bacterial Pathogens on the Feet
timeFrame: 4 weeks after stopping the intervention (approximately 13 months after randomization)
Other outcomes:
measure: Time to New Foot Complication Among Participants With a Healed Foot Complication at Randomization.
timeFrame: 12 months
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Mary-Claire Roghmann, MD
role: PRINCIPAL_INVESTIGATOR
References: