165. Outcomes of Shockwave Therapy in Diabetic Foot Ulcer Treatment: An Intention-to-treat Analysis

PURPOSE: This study aimed to evaluate the efficacy and safety of shockwave therapy in promoting wound healing in patients with diabetic foot ulcers (DFUs). The primary objective was to assess the percentage of wound area reduction and the rate of complete wound closure. METHODS: A multicenter, double-blind, randomized, placebo-controlled trial included 36 adult participants with chronic DFUs persisting for at least 30 days despite standard wound care. Participants were randomly assigned to one of three treatment arms receiving different doses of shockwave therapy or sham treatment over a 12-week period. The primary outcome was the proportion of patients achieving complete wound closure by Week 24. Secondary outcomes included wound area reduction at Weeks 15 and 24, time to wound closure, and adverse event incidence. An intention-to-treat (ITT) analysis was performed, including all randomized patients, with comparisons made using logistic regression, t-tests, and Kaplan-Meier survival analysis. RESULTS: By Week 15, patients treated with shockwave therapy experienced a significant mean wound area reduction of 70% (SD ± 18%) compared to 55% (SD ± 20%) in the control group (p = 0.009). Furthermore, 53% of patients in the shockwave therapy group achieved ≥75% wound size reduction by Week 15, compared to 47% in the control group (p = 0.042). By Week 24, 30.8% of patients in the shockwave therapy group achieved complete wound closure compared to 19.4% in the control group, although this difference did not reach statistical significance (p = 0.11). Kaplan-Meier survival analysis indicated a faster time to wound closure in the shockwave group (median time to 90% wound reduction: 47 days vs. 72 days in the control group, log-rank p = 0.08). Subgroup analyses revealed that non-smokers experienced a greater mean wound area reduction (73% ± 15%) compared to smokers (62% ± 18%) by Week 15 (p = 0.033). Patients with Type 1 diabetes showed a significantly greater reduction in wound area (74% ± 12%) compared to those with Type 2 diabetes (63% ± 19%) (p = 0.025). The number of adverse events was low and comparable between groups, with mild localized pain and transient swelling being the most common events. Serious complications were rare, and no statistically significant differences were observed between the treatment and control groups (p = 0.892). CONCLUSION: Shockwave therapy significantly enhanced wound healing in patients with DFUs, with a 70% reduction in wound area by Week 15, compared to 55% in the control group. Although complete wound closure rates by Week 24 did not reach statistical significance, the faster time to wound closure and greater response in non-smokers and Type 1 diabetes patients suggest that shockwave therapy may be particularly beneficial for select patient populations. Future research with larger cohorts and longer follow-up periods is needed to confirm these findings and explore the potential of shockwave therapy in reducing DFU recurrence and improving long-term patient outcomes.