EUSOL vs. PDGF Dressing for Diabetic Foot Ulcers | NCT07493343

Studies
EUSOL vs. PDGF Dressing for Diabetic Foot Ulcers

NCT07493343

Sponsor

Services Hospital, Lahore

Status

Completed

Last Update Posted

Mar 25, 2026Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Diabetic Wound

Interventions

EUSOL Dressing
Platelet-Derived Growth Factor (PDGF) Dressing

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 31, 2025Actual

Completion Date

Jan 10, 2026Actual

First Submitted Date

Mar 19, 2026

First Submission Date that Met QC Criteria

Mar 19, 2026

First Posted Date

Mar 25, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2026

Last Update Posted Date

Mar 25, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. SamiUllah, Principal Investigator, Services Hospital, LahorePrincipal Investigator

Lead Sponsor

Services Hospital, LahoreOTHER_GOV

Collaborators

Name	Class
Services Institute of Medical Sciences, Pakistan	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EUSOL Group	Active Comparator		Procedure: EUSOL Dressing
PDGF Group	Active Comparator		Procedure: Platelet-Derived Growth Factor (PDGF) Dressing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Awais Amjad Malik, MBBS, FCPS	Services Institute of Medical Sciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Services Institute of Medical Sciences		Lahore	Punjab Province	54000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017719	Diabetic Foot

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010982	Platelet-Derived Growth Factor
D001458	Bandages

Ancestor Terms

ID	Term
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D001798	Blood Proteins

Browse Leaves

Not provided

Browse Branches

Not provided