Randomized Comparison of Negative Pressure Wound Therapy Versus Standard Care for Diabetic Foot Ulcers to Evaluate Amputation Rates and Healing

What this Trial Is About

Researchers are comparing Negative Pressure Wound Therapy NPWT to standard wound care in patients with diabetic foot ulcers DFUs to see which is more effective in preventing major amputations and reducing surgeries and hospital stays. Diabetic foot ulcers are common and serious complications in diabetes, often leading to amputations and high healthcare costs. This study aims to clarify whether NPWT provides better outcomes than standard care by assessing amputations, mortality, wound healing, and patient quality of life. Participants will be randomly assigned to receive either NPWT or standard wound care after surgical debridement or partial amputation of the foot. NPWT involves applying suction to the wound through a sealed system with foam padding and a vacuum device, with dressings changed every 3-5 days. Standard wound care uses moist dressings that promote healing and are changed daily or every few days depending on wound condition. Both groups receive intravenous antibiotics and compression therapy as needed. The study includes 50 patients divided evenly between the two treatments. Participants will be closely followed for one year with regular outpatient visits. Researchers will monitor the number of major amputations, mortality, wound healing, complications, surgeries, hospital stay length, occupational status, and patient-reported outcomes. Adverse events will be recorded during hospital stays. The study involves questionnaires and clinical assessments at multiple time points to evaluate treatment effects and patient quality of life over the year-long follow-up.

Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy