Study Comparing Immediate Versus Delayed Weight Bearing After Surgery for Diabetic Ankle Fractures Using a Special Brace

What this Trial Is About

Diabetic patients with operatively managed ankle fractures face a high risk of complications, partly due to a loss of protective sensation that affects how pain and pressure are processed. This sensory loss increases abnormal stresses on the repaired fractures. Traditionally, diabetic patients have been kept from putting weight on the ankle for long periods, which can cause functional and cardiovascular problems. The study aims to see if immediate weight bearing with a hindfoot offloading brace after surgery maintains motion, avoids more complications than delayed weight bearing, and results in good outcomes and patient satisfaction. The study compares two postoperative rehabilitation protocols for diabetic patients who have had surgery to fix an isolated ankle fracture excluding pilon fractures within three weeks of injury. Participants are randomly assigned to either an immediate weight bearing approach using a custom hindfoot offloading brace or a delayed weight bearing approach following standard care. The brace is fitted about 1 to 2 weeks post-surgery, and patients receive education on brace use and skin care. Follow-up visits occur at multiple time points up to one year, with ankle radiographs, surveys, and brace adjustments as needed. Participants undergo assessments including hemoglobin A1c testing before surgery, radiographs, surveys measuring foot and ankle function and general health-related quality of life, and skin checks during follow-up visits. Visits happen at 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks, 16 weeks, 26 weeks, and 1 year after surgery. Researchers monitor adverse events, functional scores, and patient satisfaction over 12 months. After the study ends or if a participant leaves early, standard post-operative care and rehabilitation continue with their surgeon.

Immediate Vs. Delayed Weight Bearing Postoperative Protocol in Diabetic Ankle Fractures