Dataset Information

Moderate to Severe Soft Tissue Diabetic Foot Infections: A Randomized, Controlled, Pilot Trial of Post-Debridement Antibiotic Treatment for 10 versus 20 days.

ABSTRACT:

Background

The optimal duration of antibiotic therapy for soft-tissue infections of the diabetic foot (ST-DFI) remains unknown.

Objective

We determine if antibiotic therapy after debridement for a short (10 days), compared with a long (20 days), duration for ST-DFI results in similar rates of clinical remission and adverse events (AE).

Summary background data

The optimal duration of systemic antibiotic therapy, after successful debridement, for soft tissue infections of diabetic patients is unknown. Because of the high recurrence risk, overuse is commonplace.

Methods

This was a randomized, controlled, non-inferiority pilot trial of cases of diabetic foot infection (excluding osteomyelitis) with the primary outcome of "clinical remission at two-months follow-up".

Results

Among 66 enrolled episodes (17% females; median age 71 years), we randomized 35 to the 10-day arm and 31 to the 20-day arm. The median duration of the parenteral antibiotic therapy was 1 day, with the remainder given orally. In the intention-to-treat (ITT) population, we achieved clinical remission in 27 (77%) patients in the 10-day arm compared to 22 (71%) in the 20-days arm (p = 0.57). There were a similar proportion in each arm of AE (14/35 versus 11/31; p = 0.71), and remission in the per-protocol (PP) population (25/32 vs. 18/27; p = 0.32). Overall, eight soft tissue DFIs in the 10-day arm and five cases in the 20-day arm recurred as a new osteomyelitis (8/35 [23%] versus 5/31 [16%]; p = 0.53). Overall, the number of recurrences limited to the soft tissues was 4 (6%). By multivariate analysis, rates of remission (ITT population, hazard ratio 0.6, 95%CI 0.3-1.1; PP population 0.8, 95%CI 0.4-1.5) and AE were not significantly different with a 10-day compared to 20-day course.

Conclusions

In this randomized, controlled pilot trial, post-debridement antibiotic therapy for soft tissue DFI for 10 days gave similar (and non-inferior) rates of remission and AEs to 20 days. A larger confirmatory trial is under way.

SUBMITTER: Pham TT

PROVIDER: S-EPMC9259031 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Abstract Background Diabetic foot infections are a common precursor to lower extremity amputations. The treatment of diabetic foot infections involves both medical and surgical management, of which limb-sparing surgeries are increasingly preferred over amputations at or above the ankle to preserve mobility and quality of life. The outcomes following these limb-sparing surgeries are not well described. Methods This was a single-center, retrospective cohort study of 90 Veterans with moderate-to-severe diabetic foot infections between 2017 and 2019 from the Veterans Affairs Maryland Health Care System. The exposure was foot surgery with bone resection (ie, toe amputation, metatarsal resection, transmetatarsal amputation) vs debridement alone. The outcome was healing within 1 year. We used log-binomial regression to assess the association between foot surgery type and healing, stratify by infection location, and evaluate potential confounding variables. Results The cumulative incidence of healing after foot surgery with bone resection was greater than that following debridement (risk ratio [RR], 1.80 [95% confidence interval {CI}, 1.17–2.77]). This association was modified by infection location and greater for toe infections (RR, 4.52 [95% CI, 1.30–15.7]) than other foot infections (RR, 1.19 [95% CI, .69–2.02]). We found no evidence of confounding by comorbidities or infection severity. Conclusions For patients with toe infections, foot surgery with bone resection was associated with better healing than debridement alone. The multiple specialties caring for patients with diabetic foot infections need a stronger common knowledge base—from studies like this and future studies—to better counsel patients about their treatment and prognosis. For moderate-to-severe diabetic foot infections of the toe, we found that foot surgery with bone resection was associated with better healing than debridement. For infections of other parts of the foot, healing was similar between bone resection and debridement.