Financial burden of diabetic foot ulcers to world: a progressive topic to discuss always.
Alok Raghav, Zeeshan Ahmad Khan, Rajendra Kumar Labala...
https://pubmed.ncbi.nlm.nih.gov/29344337Actively Recruiting
Led by Kyle Schweser MD · Updated on 2025-08-24
25
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying diabetic patients who have undergone surgery for ankle fractures to determine whether starting weight bearing immediately after surgery using a special hindfoot offloading brace affects healing and complications compared to the usual practice of delayed weight bearing. The study aims to see if immediate weight bearing maintains ankle motion, does not increase complications, and leads to good patient outcomes and satisfaction. This is important because diabetic patients often have nerve damage that affects pain perception and pressure sensing, increasing the risk of complications after ankle surgery. Participants will be randomly assigned to one of two groups after their ankle surgery: one group will start immediate weight bearing using a custom-made hindfoot offloading brace designed to limit pressure on the heel, while the other group will follow a standard delayed weight-bearing protocol without the brace. The brace fitting occurs post-surgery and takes about 1-2 weeks. Follow-up visits include wound care, counseling, physical therapy, ankle X-rays, and brace adjustments at various time points up to one year. Participants will undergo regular clinical assessments including surveys measuring foot and ankle function and general health, ankle radiographs to monitor healing, and skin checks to prevent complications. Visits occur frequently in the first few months, with longer-term follow-up to one year. Safety is monitored by tracking adverse events over 12 months. If a participant leaves the study early, they continue with standard post-operative care. Total study participation can last up to one year after surgery.
CONDITIONS
Immediate Vs. Delayed Weight Bearing Postoperative Protocol in Diabetic Ankle Fractures
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants undergo surgery to fix the ankle fracture and follow either an immediate or delayed weight-bearing rehabilitation protocol using a hindfoot offloading brace or standard care.
Visits at 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks, 16 weeks, 26 weeks, and 1 year
Duration - Up to 1 year
Participants continue post-operative rehabilitation and monitoring including surveys, ankle radiographs, skin checks, and brace adjustments to assess healing and outcomes.
Multiple visits as part of treatment visits listed above
Total: 1 location
1
University of Missouri Health System
Columbia, Missouri, United States, 65212
Actively Recruiting
V
Vicki L Jones, MEd
E
Ennio Rizzo Esposito, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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