Diabetic Foot UlcerNCT07898202
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
A study testing Negative Pressure Wound Therapy and Moist Wound Dressing in people with Diabetic Foot Ulcer, run by Abbas Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Negative Pressure Wound Therapy and Moist Wound Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years, both male and female
- Patients with diabetic foot ulcer
- Ulcer size greater than 3 cm
- Patients presenting in Department of General Surgery, Abbas Institute of Medical Sciences, Muzaffarabad
- Willing to give informed consent
Who cannot join
- Patients with non-diabetic ulcers (venous ulcer, traumatic ulcer, malignant ulcer)
- Patients with osteomyelitis
- Patients with known malignancy
- Patients on immunosuppressive therapy or steroids
- Patients with severe peripheral arterial disease with absent distal pulses
- Patients not willing to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Abbas Institute of Medical Sciences Muzaffarabad
Muzaffarabad, Azad Kashmir, 13100
Dr Ahsan Ahmed, FCPS, +923000332999, khawaja.ahsanahmed@gmail.com
About this study
Official title: Comparison of the Efficacy of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
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.
Read the detailed description
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
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Negative Pressure Wound Therapy, Moist Wound Dressing
- Keywords
- Negative pressure wound therapy, Moist wound dressing, Diabetic Foot Ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound TherapyDevice
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 DressingOther
Moist wound dressing with normal saline soaked gauze, dressing changed daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | NPWT applied with vacuum assisted closure device, 100-125 mmHg, changed every 48-72 hours for 4 weeks Receives: Device: Negative Pressure Wound Therapy |
| Moist Wound Dressing | Active comparator | Moist wound dressing with normal saline soaked gauze, changed daily for 4 weeks Receives: Other: Moist Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
Reduction in ulcer size
Change in ulcer size from baseline to 4 weeks, measured in cm^2
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients presenting to Department of General Surgery, Abbas Institute of Medical Sciences, Muzaffarabad with diabetic foot ulcer \>3 cm will be enrolled. After informed consent, they will be randomized by lottery method into Group A (Negative Pressure Wound Therapy) and Group B (Moist Wound Dressing). Efficacy will be measured after 4 weeks as healing in ≤4 weeks and ≥3 cm reduction in ulcer size. Healing time will be recorded. Data will be analyzed using SPSS.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbas Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahsan Ahmed, Abbas Institute of Medical Sciences
- Investigators
- Ahsan Ahmed, FCPS, Principal investigator, Abbas Institute of Medical Sciences Muzaffarabad.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898202
- Sponsor's protocol ID
- AbbasIMS
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
- ClinicalTrials.gov ID
- NCT07898202
- Acronym / sponsor ID
- AbbasIMS
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Negative pressure wound therapy, Moist wound dressing, Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Abbas Institute of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients presenting to Department of General Surgery, Abbas Institute of Medical Sciences, Muzaffarabad with diabetic foot ulcer >3 cm will be enrolled. After informed consent, they will be randomized by lottery method into Group A (Negative Pressure Wound Therapy) and Group B (Moist Wound Dressing). Efficacy will be measured after 4 weeks as healing in ≤4 weeks and ≥3 cm reduction in ulcer size. Healing time will be recorded. Data will be analyzed using SPSS.
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Device: Negative Pressure Wound TherapyNPWT applied with vacuum assisted closure device, 100-125 mmHg, changed every 48-72 hours for 4 weeks |
| Moist Wound Dressing | Active comparator | Other: Moist Wound DressingMoist wound dressing with normal saline soaked gauze, changed daily for 4 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-70 years, both male and female
- Patients with diabetic foot ulcer
- Ulcer size greater than 3 cm
- Patients presenting in Department of General Surgery, Abbas Institute of Medical Sciences, Muzaffarabad
- Willing to give informed consent
Key exclusion criteria (6 listed)
- Patients with non-diabetic ulcers (venous ulcer, traumatic ulcer, malignant ulcer)
- Patients with osteomyelitis
- Patients with known malignancy
- Patients on immunosuppressive therapy or steroids
- Patients with severe peripheral arterial disease with absent distal pulses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Pressure Wound TherapyNPWT will be applied using Vacuum Assisted Closure device at 100-125 mmHg pressure, dressing changed every 48-72 hours for 4 weeks | Device | Negative Pressure Wound Therapy |
| Moist Wound DressingMoist wound dressing with normal saline soaked gauze, dressing changed daily for 4 weeks | Other | Moist Wound Dressing |
Primary outcome
Efficacy of Negative Pressure Wound Therapy versus Moist Wound Dressing
Time frame: 4 weeks
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.
1 secondary outcome
Reduction in ulcer size
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No. No plan to share individual participant data
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahsan Ahmed, FCPS principal investigator
Abbas Institute of Medical Sciences Muzaffarabad.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Wound Therapy and Moist Wound Dressing in people with Diabetic Foot Ulcer, run by Abbas Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahsan Ahmed, FCPS (+923000332999, khawaja.ahsanahmed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Negative Pressure Wound Therapy versus Moist Wound Dressing (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.