Preventing Diabetic Foot Ulcers Through Cleaner Feet
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/20/2019 |
| Start Date: | January 2, 2019 |
| End Date: | June 30, 2023 |
Preventing Diabetic Foot Ulcers Through Manipulating the Skin Microbiota
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.
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.
Population: Up to 200 Veterans at risk for diabetic foot ulcer recurrence
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 recurrence 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
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 recurrence 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
Inclusion Criteria:
- Adults >=18 years
- Clinical diagnosis of diabetes
- Recent (within 18 months) history of 1)foot ulcer or wound or 2) toe amputation or
3)transmetatarsal amputation or 4)foot infection which has healed
- Two feet (can have toe amputation or transmetatarsal amputation)
- 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:
- 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
- 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
We found this trial at
1
site
Baltimore, Maryland 21201
Principal Investigator: Mary-Claire Roghmann, MD
Phone: 410-706-0062
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