Diabetic WoundNCT07493343
EUSOL vs. PDGF Dressing for Diabetic Foot Ulcers
A study testing EUSOL Dressing and Platelet-Derived Growth Factor (PDGF) Dressing in people with Diabetic Wound, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial summary
Diabetic foot ulcers are a major cause of morbidity and amputation. This randomized controlled trial will compare the efficacy of a traditional antiseptic dressing (EUSOL) with a modern biologic dressing containing Platelet-Derived Growth Factor (PDGF) in promoting wound contraction. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetic Wound
- What is being tested?
- EUSOL Dressing and Platelet-Derived Growth Factor (PDGF) Dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2020to 10 Jan 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetes mellitus.
- Presence of a Grade II Wagner diabetic foot ulcer (penetrating to subcutaneous tissue, without involvement of tendon, bone, or joint).
- Ulcer size less than 6 x 6 cm at baseline.
Who cannot join
- Uncontrolled diabetes
- Malnourished (BMI less than 20)
- HB less than 10
- ABPI less than 0.9
- Immunosuppression therapy
- Patients with malignancy or uncontrolled cardiopulmonary, neurological, or psychiatric disease.
- Severe active infection
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Services Institute of Medical Sciences
Lahore, Punjab Province, 54000
About this study
Official title: Comparison of EUSOL Dressing Versus Platelet Derived Growth Factor Dressing in Wound Contraction of Grade II Wagner Diabetic Foot Ulcers: A Randomized Controlled Trial
Diabetic foot ulcers are a major cause of morbidity and amputation. This randomized controlled trial will compare the efficacy of a traditional antiseptic dressing (EUSOL) with a modern biologic dressing containing Platelet-Derived Growth Factor (PDGF) in promoting wound contraction. The study aims to determine if PDGF dressing leads to better healing outcomes in patients with Grade II Wagner diabetic foot ulcers.
- Conditions
- Diabetic Wound
- Being tested
- EUSOL Dressing, Platelet-Derived Growth Factor (PDGF) Dressing
- Keywords
- Diabetic Foot Ulcer, Wagner Grade II, Wound Healing, Platelet-Derived Growth Factor, EUSOL
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUSOL DressingProcedure or surgery
Daily dressing with freshly prepared Edinburgh University Solution of Lime (EUSOL) applied to the ulcer after standard debridement and cleansing.
Platelet-Derived Growth Factor (PDGF) DressingProcedure or surgery
PDGF-based topical preparation applied to the ulcer surface every fourth day, covered by a secondary dressing. Interim dressing changes used normal saline only.
| Study group | Role | What they receive |
|---|---|---|
| EUSOL Group | Active comparator | Not described Receives: Procedure: EUSOL Dressing |
| PDGF Group | Active comparator | Not described Receives: Procedure: Platelet-Derived Growth Factor (PDGF) Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving wound contraction.
Wound healing will be defined as the achievement of at least a 50% reduction in ulcer area from baseline after four weeks of treatment. Ulcer area will be calculated as maximum length multiplied by maximum width.
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 posted25 Mar 2026
- Study start1 Jan 2020
- Primary completion31 Dec 2025
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Collaborators
- Services Institute of Medical Sciences, Pakistan
- Responsible party
- Principal investigator, Dr. SamiUllah, Services Hospital, Lahore
- Investigators
- Awais Amjad Malik, MBBS, FCPS, Study director, Services Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493343
- Sponsor's protocol ID
- RCT28SIMS
- Status last verified
- Feb 2026
- First submitted
- 19 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of EUSOL Dressing Versus Platelet Derived Growth Factor Dressing in Wound Contraction of Grade II Wagner Diabetic Foot Ulcers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07493343
- Acronym / sponsor ID
- RCT28SIMS
- Conditions
- Diabetic Wound
- Keywords
- Diabetic Foot Ulcer, Wagner Grade II, Wound Healing, Platelet-Derived Growth Factor, EUSOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Collaborators
- Services Institute of Medical Sciences, Pakistan
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 25 Mar 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 ulcers are a major cause of morbidity and amputation. This randomized controlled trial will compare the efficacy of a traditional antiseptic dressing (EUSOL) with a modern biologic dressing containing Platelet-Derived Growth Factor (PDGF) in promoting wound contraction. The study aims to determine if PDGF dressing leads to better healing outcomes in patients with Grade II Wagner diabetic foot ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUSOL Group | Active comparator | Procedure: EUSOL Dressing |
| PDGF Group | Active comparator | Procedure: Platelet-Derived Growth Factor (PDGF) Dressing |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of diabetes mellitus.
- Presence of a Grade II Wagner diabetic foot ulcer (penetrating to subcutaneous tissue, without involvement of tendon, bone, or joint).
- Ulcer size less than 6 x 6 cm at baseline.
Key exclusion criteria (7 listed)
- Uncontrolled diabetes
- Malnourished (BMI less than 20)
- HB less than 10
- ABPI less than 0.9
- Immunosuppression therapy
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 |
|---|---|---|
| EUSOL DressingDaily dressing with freshly prepared Edinburgh University Solution of Lime (EUSOL) applied to the ulcer after standard debridement and cleansing. | Procedure or surgery | EUSOL Group |
| Platelet-Derived Growth Factor (PDGF) DressingPDGF-based topical preparation applied to the ulcer surface every fourth day, covered by a secondary dressing. Interim dressing changes used normal saline only. | Procedure or surgery | PDGF Group |
Primary outcome
Proportion of patients achieving wound contraction.
Time frame: 4 weeks
Wound healing will be defined as the achievement of at least a 50% reduction in ulcer area from baseline after four weeks of treatment. Ulcer area will be calculated as maximum length multiplied by maximum width.
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 25 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Awais Amjad Malik, MBBS, FCPS study director
Services Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUSOL Dressing and Platelet-Derived Growth Factor (PDGF) Dressing in people with Diabetic Wound, run by Services Hospital, Lahore 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 7 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 25 Mar 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?
Proportion of patients achieving wound contraction. (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 25 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.