Infected WoundNCT07795489
Vacuum-assisted Closure Versus Conventional Dressings in Infected Lower-limb Wounds
A study testing Vacuum-Assisted Closure (VAC) Therapy and Conventional dressing in people with Infected Wound and Diabetic Wound, run by Sargodha Medical College at 1 site in Pakistan.
Trial summary
Wound healing is a complex and dynamic process that includes an immediate sequence of cell migration leading to repair and closure. Delayed wound healing or non-healing of ulcers is a significant health problem, particularly in older adults. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Infected Wound, Diabetic Wound
- What is being tested?
- Vacuum-Assisted Closure (VAC) Therapy and Conventional dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Jul 2025to 24 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult population aged 18 - 40 years.
- Gender;both male and female.
- Patients having infected wound of lower limb (as per operational definition).
Who cannot join
- > Recurrent cases (on medical record)
- Patients with metabolic diseases, taking steroids, with peripheral vascular disease, cancer.
- Patients with complications such as septic shock, diabetic ketoacidosis, or kidney injuries (on medical record)
- Patients whose vitals were unstable (on clinical examination and medical record)
- Patients with any evidence of underlying bone osteomyelitis and malignancy (on medical record).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dr Faisal Masood teaching Hospital Sargodha
Sargodha, Punjab Province, 40100
About this study
Official title: Comparison of Vacuum-assisted Closure Versus Conventional Wound Dressings in the Management of Infected Lower-limb Wounds
Wound healing is a complex and dynamic process that includes an immediate sequence of cell migration leading to repair and closure. Delayed wound healing or non-healing of ulcers is a significant health problem, particularly in older adults. Vacuum assisted closure (VAC) is a relatively new technology with applications in a variety of difficult to manage acute and chronic wounds. Literature showed that the outcomes of VAC is a better than other method. Therefore, this study has been planned. This Randomized controlled trial will be done at Department of General Surgery, Dr Faisal Masood Teaching Hospital, Sargodha for 12 months.Sample size of 90 cases; 45 in each groups will be included through Non-probability consecutive sampling and will be randomly divided into 2 equal groups. In group A, VAC will be applied to wound. In group B, conventional dressing will be applied on wound. Wound size after one week will be assessed. If wound will heal completely, then duration for complete healing will be noted. Success will also be noted. All the data will be recorded in proforma.All the data will be analyzed with SPSS version 25. Both groups will be compared by using independent samples t-test for duration of healing, and wound size after a week and chi-square test for success. P-value ≤ 0.05 will be considered as significant. Conclusion and recommendations will be made to obtain better results with high success rate, which will lead to better quality of life and early discharge of patients.
- Conditions
- Infected Wound, Diabetic Wound
- Being tested
- Vacuum-Assisted Closure (VAC) Therapy, Conventional dressing
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum-Assisted Closure (VAC) TherapyDevice
Application of vacuum-assisted closure (VAC) therapy to infected lower-limb wounds using negative pressure wound therapy, with appropriate wound preparation and dressing changes according to the study protocol."
Conventional dressingOther
Routine conventional dressing of infected lower-limb wounds using standard wound-care techniques and appropriate dressing materials, with dressing changes performed according to the study protocol."
| Study group | Role | What they receive |
|---|---|---|
| VAC Therapy | Experimental | Participants will receive vacuum-assisted closure (VAC) therapy for management of infected lower-limb wounds. Receives: Device: Vacuum-Assisted Closure (VAC) Therapy |
| Conventional Dressing | Active comparator | Participants will receive conventional wound dressing for management of infected lower-limb wounds. Receives: Other: Conventional dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wound size
Measured: 7 days after initiation of treatment
Secondary outcomes (1)
Treatment success rate
Measured: Within two weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start16 Jul 2025
- Primary completion14 Aug 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infected WoundStudies 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
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sargodha Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795489
- Sponsor's protocol ID
- SMC-GS-2026-0013
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vacuum-assisted Closure Versus Conventional Wound Dressings in the Management of Infected Lower-limb Wounds
- ClinicalTrials.gov ID
- NCT07795489
- Acronym / sponsor ID
- SMC-GS-2026-0013
- Conditions
- Infected Wound, Diabetic Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sargodha Medical CollegeUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 14 Aug 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 31 Aug 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.
Wound healing is a complex and dynamic process that includes an immediate sequence of cell migration leading to repair and closure. Delayed wound healing or non-healing of ulcers is a significant health problem, particularly in older adults. Vacuum assisted closure (VAC) is a relatively new technology with applications in a variety of difficult to manage acute and chronic wounds. Literature showed that the outcomes of VAC is a better than other method. Therefore, this study has been planned. This Randomized controlled trial will be done at Department of General Surgery, Dr Faisal Masood Teaching Hospital, Sargodha for 12 months.Sample size of 90 cases; 45 in each groups will be included through Non-probability consecutive sampling and will be randomly divided into 2 equal groups. In group A, VAC will be applied to wound. In group B, conventional dressing will be applied on wound. Wound size after one week will be assessed. If wound will heal completely, then duration for complete healing will be noted. Success will also be noted. All the data will be recorded in proforma.All the data will be analyzed with SPSS version 25. Both groups will be compared by using independent samples t-test for duration of healing, and wound size after a week and chi-square test for success. P-value ≤ 0.05 will be considered as significant. Conclusion and recommendations will be made to obtain better results with high success rate, which will lead to better quality of life and early discharge of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAC Therapy | Experimental | Device: Vacuum-Assisted Closure (VAC) TherapyParticipants will receive vacuum-assisted closure (VAC) therapy for management of infected lower-limb wounds. |
| Conventional Dressing | Active comparator | Other: Conventional dressingParticipants will receive conventional wound dressing for management of infected lower-limb wounds. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult population aged 18 - 40 years.
- Gender;both male and female.
- Patients having infected wound of lower limb (as per operational definition).
Key exclusion criteria (5 listed)
- > Recurrent cases (on medical record)
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 |
|---|---|---|
| Vacuum-Assisted Closure (VAC) TherapyApplication of vacuum-assisted closure (VAC) therapy to infected lower-limb wounds using negative pressure wound therapy, with appropriate wound preparation and dressing changes according to the study protocol." | Device | VAC Therapy |
| Conventional dressingRoutine conventional dressing of infected lower-limb wounds using standard wound-care techniques and appropriate dressing materials, with dressing changes performed according to the study protocol." | Other | Conventional Dressing |
Primary outcome
Change in wound size
Time frame: 7 days after initiation of treatment
1 secondary outcome
Treatment success rate
Time frame: Within two weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum-Assisted Closure (VAC) Therapy and Conventional dressing in people with Infected Wound and Diabetic Wound, run by Sargodha Medical College 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 3 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wound size (time frame: 7 days after initiation of treatment). 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 3 Sep 2026.