An interventional study of Negative Pressure Wound Therapy and Moist Wound Dressing in Diabetic Foot Ulcer, sponsored by Abbas Institute of Medical Sciences. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Abbas Institute of Medical Sciences · Not applicable, Interventional, and Treatment
Diabetic foot ulcer is a common and disabling complication of diabetes mellitus. This randomized controlled trial will be conducted at Abbas Institute of Medical Sciences, Muzaffarabad to compare the efficacy of negative pressure wound therapy versus conventional moist wound dressing. A total of 60 patients aged 18-70 years with diabetic foot ulcer size greater than 3 cm will be randomly divided into two groups of 30 patients each. Group A will receive negative pressure wound therapy and Group B will receive moist wound dressing. Efficacy will be measured in terms of healing time and reduction in ulcer size after 4 weeks of treatment.
This is a randomized controlled trial to be conducted in Department of General Surgery, Abbas Institute of Medical Sciences, Muzaffarabad. After approval from ethical review committee and CPSP, 60 patients presenting in outpatient Department of Surgery fulfilling inclusion criteria will be selected after informed consent. Patients will be randomized by lottery method into Group A and Group B. In Group A, negative pressure wound therapy will be applied using Vacuum Assisted Closure device at 100-125 mmHg, dressing changed every 48-72 hours, no less than two times per week. In Group B, moist wound dressing with normal saline will be applied daily. Age, gender, duration of ulcer, size of ulcer, BMI, HbA1c will be noted. Ulcer size will be measured as product of two largest perpendicular diameters in cm2 at presentation and after 4 weeks. Healing time will be measured in days from application of first dressing to appearance of granulation tissue. Efficacy is defined as healing in 4 weeks and greater than 3 cm reduction in ulcer size. Data will be analyzed in SPSS. Hypothesis is that efficacy of negative pressure wound therapy is better than moist wound dressing in diabetic foot ulcer patients
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →This is the only study on the registry with Abbas Institute of Medical Sciences as lead sponsor.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Cancer (malignancy)
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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NPWT applied with vacuum assisted closure device, 100-125 mmHg, changed every 48-72 hours for 4 weeks
Device: Negative Pressure Wound Therapy
Moist wound dressing with normal saline soaked gauze, changed daily for 4 weeks
Other: Moist Wound Dressing
NPWT will be applied using Vacuum Assisted Closure device at 100-125 mmHg pressure, dressing changed every 48-72 hours for 4 weeks
Moist wound dressing with normal saline soaked gauze, dressing changed daily for 4 weeks
Efficacy of Negative Pressure Wound Therapy versus Moist Wound Dressing
Efficacy defined as wound healing within 4 weeks and greater than 3 cm reduction in ulcer size. Ulcer size measured as product of two largest perpendicular diameters in cm\^2 . Healing time measured in days from application of first dressing to appearance of granulation tissue.
Time frame: 4 weeks
Reduction in ulcer size
Change in ulcer size from baseline to 4 weeks, measured in cm\^2
Time frame: 4 weeks
Plan to share: No — No plan to share individual participant data
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.
Of 240 non-industry interventional studies with no phase under Diabetic Foot, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 6 months is below that.
Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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