- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07493343
EUSOL vs. PDGF Dressing for Diabetic Foot Ulcers
March 19, 2026 updated by: Dr. SamiUllah, Services Hospital, Lahore
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Services Institute of Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: EUSOL Group
|
Daily dressing with freshly prepared Edinburgh University Solution of Lime (EUSOL) applied to the ulcer after standard debridement and cleansing.
|
|
Active Comparator: PDGF Group
|
PDGF-based topical preparation applied to the ulcer surface every fourth day, covered by a secondary dressing.
Interim dressing changes used normal saline only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Awais Amjad Malik, MBBS, FCPS, Services Institute of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
December 31, 2025
Study Completion (Actual)
January 10, 2026
Study Registration Dates
First Submitted
March 19, 2026
First Submitted That Met QC Criteria
March 19, 2026
First Posted (Actual)
March 25, 2026
Study Record Updates
Last Update Posted (Actual)
March 25, 2026
Last Update Submitted That Met QC Criteria
March 19, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Diabetes Mellitus
- Diabetic Angiopathies
- Diabetes Complications
- Skin Diseases
- Skin Ulcer
- Leg Ulcer
- Diabetic Neuropathies
- Foot Ulcer
- Skin and Connective Tissue Diseases
- Diabetic Foot
- Peptides
- Amino Acids, Peptides, and Proteins
- Proteins
- Biological Factors
- Equipment and Supplies
- Blood Proteins
- Intercellular Signaling Peptides and Proteins
- Bandages
- Platelet-Derived Growth Factor
Other Study ID Numbers
- RCT28SIMS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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