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IRCT20231201060234N2 IRCT 2024-07-08 CMH Peshawar Negative pressure versus standard wound therapy for diabetic foot Comparison between negative pressure wound therapy versus standard wound care in diabetic foot patients at a tertiary care hospital 2023-01-01 anticipated 160 Complete https://irct.ir/trial/74221 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We made two groups of 95 patients each, one to receive standard dressing care and one to receive NPWT randomized through non-probability consecutive sampling via lottery method according to the inclusion criteria furnished. Simple randomization was done. Allocation concealment was carried out through envelopes and residents unaware of the study protocol, Blinding description: Since procedural limitations did not allow blinding during the study, the endpoint of wound healing and size regression was assessed by an independent team of 3 consultants who were given the final results of the wounds in pictorial form to give their opinion of the changes before and after treatment and debridement. Data analysis consultant was also blinded to the study protocol with data given as Group N and Group S. 2-3 Diabetic foot ulcers. Intervention 1: Intervention group: Negative pressure wound therapy group (NPWT) (n=95) Patients in Group N received NPWT after debridement on admission in the hospital and were followed up for 12 weeks to assess for complete healing with 100% epithelization and fit for surgical closure. A standard sub-atmospheric pressure of 120 mmHg was applied on the debrided ulcer through a sealed wound attached to a suction pump. Patients were followed up for up to 12 weeks and primary and secondary variables noted by an independent surgical consultant unaware of the study protocol. Intervention 2: Intervention group: Standard moist wound therapy group (n=95) Patients in Group S received standard modern moist wound dressing after debridement and followed up for the same after complete epithelization and tissue formation for up to 12 weeks. Yes - There is a plan to make this available What will be shared: The word file along with SPSS data set and output sheet would be shared once the article gets accepted and published When: Will be available after manuscript approval and would be able to download and use for five years To whom: only for academic purposes Conditions: will be provided after official approval from primary author through email and link would be sent to download the data set from online backup repository Where to obtain: Application to access data through official email of the primary author provided in the trial How to obtain: will be provided after official approval from primary author through email and link would be sent to download the data set from online backup repository total time would be 7-10 working days Comments:
public Rashid Ali
D7
Rawalpindi Pakistan 46000 +92 81 2850639 Rashid_zahidbaloch@hotmail.com CMH Rwp scientific Rashid Ali
D7
Rawalpindi Pakistan 46000 +92 81 2850639 Rashid_zahidbaloch@hotmail.com CMH Rwp Pakistan Included all patients >18 years diagnosed clinically and BSF and 2-hour-post prandial investigations in the diabetic range according to the WHO criteria Presenting with a diabetic foot wound of more than 4 weeks duration corresponding to Wagner grade 2 for debridement. 18 years no limit Both Included patients < 18 years Pregnancy Non-compliant to follow-up Necrotic tissue on ulcer with eschar that could not be debrided Malignancy, advanced cardiac and respiratory disease Exposed nerve and vessels beneath the ulcer and patient with above ankle ulcer and those with Charcot arthropathy. Z86.31 Personal history of diabetic foot ulcer Treatment - Other Treatment - Other Intervention group: Negative pressure wound therapy group (NPWT) (n=95) Patients in Group N received NPWT after debridement on admission in the hospital and were followed up for 12 weeks to assess for complete healing with 100% epithelization and fit for surgical closure. A standard sub-atmospheric pressure of 120 mmHg was applied on the debrided ulcer through a sealed wound attached to a suction pump. Patients were followed up for up to 12 weeks and primary and secondary variables noted by an independent surgical consultant unaware of the study protocol. Intervention group: Standard moist wound therapy group (n=95) Patients in Group S received standard modern moist wound dressing after debridement and followed up for the same after complete epithelization and tissue formation for up to 12 weeks. Mean wound closure time. Timepoint: During or after 12 weeks of therapy. Method of measurement: Subjective assessment by 3 consultants. Median pain scores. Timepoint: After 12 weeks of therapy. Method of measurement: Standard Visual Analog Scale for pain and Likert scale for satisfaction. Incidence of infection. Timepoint: During 12 weeks of therapy. Method of measurement: Subjective by 3 independent consultants. CMH Peshawar Approved 2022-12-22 Ethical review board CMH Peshawar CMH Road Peshawar KPK Pakistan