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IRCT20260612069759N1 IRCT 2026-07-12 Combined Military Hospital, rawalpindi Primary vs delayed closure after below-knee amputation in diabetic foot patients. Comparison of post-surgical infection frequency, mean length of hospital stay, and surgical outcomes between primary and delayed primary stump closure in diabetic patients undergoing below-knee amputation for diabetic foot 2025-01-01 anticipated 220 Complete https://irct.ir/trial/90844 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients were individually randomized in a 1:1 ratio to either primary closure or delayed primary closure using simple randomization by drawing method. At the time of enrollment, each patient drew a pre-prepared slip indicating allocation to one of the two study groups, Blinding description: Patients were not informed of the specific study hypothesis to minimize expectation bias. Outcome assessments were performed by investigators who were blinded to the treatment allocation. Data analysis was also conducted by blinded investigators to ensure objective interpretation of the study results. 2-3 diabetic foot amputation stump. Intervention 1: Intervention group 1:Primary stump closure. Patients undergoing below-knee amputation with immediate closure of the stump at the time of surgery. Intervention 2: Intervention group 2:Delayed primary stump closure. Patients undergoing below-knee amputation in whom stump closure is performed 72 hours after the initial surgery following wound assessment, wound washing, and antiseptic dressing. Yes - There is a plan to make this available What will be shared: De-identified participant data, study protocol, statistical analysis plan, and final clinical study report related to primary versus delayed primary stump closure in below-knee amputation for diabetic foot will be made available after publication. When: After Publication of article To whom: medical students and people working in medical institutions Conditions: only for educational purposes not for commercial purposes after publication and approval from primary author Where to obtain: Data can be obtained from google drive after sending request to email Wahidmalik973@outlook.com. link for Google drive will be shared to get the data access. How to obtain: an email will be required and approval will be given by primary author for using the data Comments:
public Abdul Wahid
House number 142, K-1 block, WAPDA Town, Lahore, Punjab, Pakistan
Lahore Pakistan 54770 +92 332 9851374 Wahidmalik973@outlook.com Combined Military Hospital, Rawalpindi scientific Abdul Wahid
House number 142, K-1 block, WAPDA Town, Lahore, Punjab, Pakistan
Lahore Pakistan 54770 +92 332 9851374 Wahidmalik973@outlook.com Combined Military Hospital Rawalpindi ,Pakistan Pakistan All male or female diabetic patients Aged 18-75 years of age on treatment Either oral medication or on insulin Presenting for below knee amputation of a single non-salvageable limb with infection below the level of amputation 18 years 75 years Both Patients with advanced cardiac or respiratory disease Those planned for a guillotine amputation Patients with inadequate skin cover for stump formation Patients unwilling to be included in the study Z86.31 Personal history of diabetic foot ulcer Treatment - Surgery Treatment - Surgery Intervention group 1:Primary stump closure. Patients undergoing below-knee amputation with immediate closure of the stump at the time of surgery. Intervention group 2:Delayed primary stump closure. Patients undergoing below-knee amputation in whom stump closure is performed 72 hours after the initial surgery following wound assessment, wound washing, and antiseptic dressing. Surgical Site infection. Timepoint: Postoperative day 7 and 28. Method of measurement: Clinical wound assessment for pus discharge, foul smell or any signs of infection. Length of hospital stay. Timepoint: At time of discharge from hospital. Method of measurement: Total number of days from surgery to discharge from hospital will be counted. Need for readmission after infection. Timepoint: Within 28 days after surgery. Method of measurement: Follow up visits for infection related readmission and hospital admission record. Revision of the procedure. Timepoint: Within 28 days after surgery. Method of measurement: Below knee amputation stump assessment for requirement of additional surgery. 28 days mortality. Timepoint: Within 28 days after surgery. Method of measurement: Hospital records and follow-up information. Self Approved 2024-12-17 Ethical Committee, Institutional Review Board Combined Military Hospital Rawalpindi Tamiz-ud-din road, lalkurti, Rawalpindi Cantt Rawalpindi Punjab Pakistan