EUSOL vs. PDGF Dressing for Diabetic Foot Ulcers

NCT07493343 | Completed DMC

• 1 other identifier: RCT28SIMS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Diabetic Foot Ulcer; Wagner Grade II; Wound Healing; Platelet-Derived Growth Factor; EUSOL

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Study Arms (2)

EUSOL Group

ACTIVE COMPARATOR

Procedure: EUSOL Dressing

PDGF Group

ACTIVE COMPARATOR

Procedure: Platelet-Derived Growth Factor (PDGF) Dressing

Interventions

EUSOL Dressing PROCEDURE

Daily dressing with freshly prepared Edinburgh University Solution of Lime (EUSOL) applied to the ulcer after standard debridement and cleansing.

EUSOL Group

Platelet-Derived Growth Factor (PDGF) Dressing PROCEDURE

PDGF-based topical preparation applied to the ulcer surface every fourth day, covered by a secondary dressing. Interim dressing changes used normal saline only.

PDGF Group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Services Hospital, Lahore: lead
• Services Institute of Medical Sciences, Pakistan: collaborator

Study Sites (1)

Services Institute of Medical Sciences

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Platelet-Derived Growth Factor; Bandages

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Blood Proteins; Proteins; Biological Factors; Equipment and Supplies

Study Officials

• Awais Amjad Malik, MBBS, FCPS

  Services Institute of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 25, 2026
• Study Start: January 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: January 10, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-02

Locations

PA (1)