Diabetes is common in the Veterans Health Administration (VHA) patient population with a prevalence of 24% making it a priority clinical issue for Veterans. Between 10 and 25% of people with diabetes will develop a foot ulcer during their lifetime. Diabetic foot ulcers are a leading cause of hospitalization, as well as the primary cause of lower limb amputations. About 5% of patients with a foot ulcer require an amputation each year, typically due to the development of infection at the site of the foot ulcer. Because foot ulcers are a leading cause of disability in people with diabetes, more effective prevention is needed. The role of the skin microbiota on the development of chronic foot ulcers after minor trauma is unknown. Prior work has shown that the feet of diabetic Veterans had a higher load of S. aureus compared with non-diabetic veterans. Our preliminary data suggest that there are higher loads of S. aureus and total bacteria on the feet of diabetic Veterans at high risk for future foot ulcer compared to diabetic Veterans at low risk of a future foot ulcer. If so, manipulating the skin microbiota of the feet could reduce the risk of foot complications. Thus, we propose the following aims to test our central hypotheses that the skin microbiota is part of the causal pathway in the development of chronic ulcers. Using a randomized, double-blind clinical trial, 200 adults with diabetes and a prior foot ulcer will be randomly assigned to chlorhexidine or placebo wipes for daily foot care over one year.
Specific Aim 1 A: To determine if chlorhexidine reduces the recurrence of foot complications including chronic foot ulcer, foot infection or foot amputation. We hypothesize that the chlorhexidine group will have a lower incidence of chronic foot ulcer or foot infection or foot amputation than the placebo group.
Specific Aim 1 B: To determine if chlorhexidine increases antibiotic resistance among ESKAPE [and diabetic foot infection] pathogens. We hypothesize that a) the chlorhexidine group will not be colonized with E. cloacae, S. aureus, K. pneumoniae, A. baumannii, P. aeruginosa and E. faecium (ESKAPE) [and diabetic foot infection] pathogens with a higher MIC to chlorhexidine than the placebo group and b) the chlorhexidine group will not be colonized with ESKAPE [and diabetic foot infection] pathogens with a higher MIC to key antibiotics than the placebo group. We expect to gain: 1) an assessment of the feasibility of chlorhexidine as a daily intervention to prevent recurrent foot ulcers in Veterans with diabetes, and 2) an understanding of the risk of antimicrobial resistance with long term chlorhexidine use. Our long term goal is to test whether interventions which manipulate the skin microbiota prevent foot ulcers in a larger (adequately powered for a clinically relevant endpoint) clinical trial in order to reduce the risk of amputation associated with diabetic foot ulcers.
Diabetes is common in the Veterans Health Administration (VHA) patient population. One in four Veterans have diabetes- making it a priority clinical issue for Veterans? care. Between 10 and 25% of people with diabetes will develop a foot ulcer. About 5% per year of patients with a foot ulcer require an amputation, typically due to the development of infection and then gangrene at the site of the foot ulcer. An estimated 80,000 people with diabetes require lower extremity amputation each year. Because foot ulcers are a leading cause of amputation in people with diabetes, more effective prevention measures are needed.