Efficacy and Safety of Wharton's Jelly-Derived Mesenchymal Stem Cell Exosomes in the Treatment of Diabetic Foot Ulcers: A Double-blinded Randomized Controlled Clinical Trial

NCT06812637 | Completed Phase 1

• 1 other identifier: WJ-MSC-exo in diabetic foot
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Study effeciency and safety of WJ-MSC derived exosomes in DFU healing

Conditions

Diabetic Foot Ulcer (DFU); Exosomes

Keywords

Exosomes; Diabetic foot ulcer; WJ-MSC

Outcome Measures

Primary Outcomes (1)

• Ulcer healing

  measuring the percent of wound closure compared to the baseline

  20 week

Study Arms (3)

Treated group

EXPERIMENTAL

40 patients received standard of care (SOC) with Wharton jelly derived mesenchymal stem cell (WJ - MSC) exosome gel once weekly for 4 weeks followed by follow up for 16 weeks

Drug: WJ-MSC- Exosomes; Combination Product: SOC (Standard of care)

Control group

OTHER

35 patients received standard of care (SOC) only for 4 weeks followed by follow-up for 16 weeks.

Placebo group

PLACEBO COMPARATOR

35 patients received received a visually identical saline-based formulation once weekly for 4 weeks followed by follow up for 16 weeks together with SOC

Interventions

WJ-MSC- Exosomes DRUG

warton jelly derived mesenschymal stem cell derived exosomes dissolved in CMC

Treated group

SOC (Standard of care) COMBINATION_PRODUCT

Wound depridement for necrotic parts , local antibiotic , dressing , unloading

Treated group

Vehicle (placebo) OTHER

Vehicle for the MSC-EXO

Eligibility Criteria

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

You may qualify if:

• \. Presence of a chronic DFU persisting for more than six weeks or showing less than 30% reduction in size after a seven-day standard of care (SOC) management.
• \. Ulcers located on the plantar, medial, or lateral aspects of the foot with a size \<30 cm².
• \. Patients with neuropathic, ischemic, or mixed neuropathic-ischemic ulcers. 5. Revascularization performed for ischemic ulcers before enrollment.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

kafr elshaikh university Hospital

Kafrelsheikh, Kafrelsheikh, 33511, Egypt

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

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)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: This was a prospective, randomized, double-blind, placebo-controlled clinical trial conducted to evaluate the efficacy and safety of WJ-MSC-derived exosomes gel in patients with diabetic foot ulcers (DFUs).

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 6, 2025
• Study Start: April 6, 2024
• Primary Completion: June 6, 2024
• Study Completion: September 2, 2024
• Last Updated: April 29, 2025

Record last verified: 2025-02

Locations

EG (1)