Overview

Clinical Application of Mesenchymal Stem Cells Seeded in Chitosan Scaffold for Diabetic Foot Ulcers

Status:
Unknown status

Trial end date:
2019-01-01

Target enrollment:
0

Participant gender:
All

Summary

This study will assess the efficacy of application of stem cell in healing of chronic diabetic foot ulcer

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Assiut University

Treatments:

Chitosan

Criteria

Inclusion Criteria:

1. Diabetic patient with diagnosis of neuropathic or neuro-ischemic DFU

2. Chronic non healed diabetic foot ulcer (The wound was determined as non-healing and
chronic when the wound was treated with current standard care for diabetic foot ulcer
by a wound care specialist for at least 3 months prior to the therapy with less than
40% of wound closure)

3. Strict diabetes control with HbA1c ≤ 7.5%

4. Grade 1 or 2 ulcer on the Wagner scale

Exclusion Criteria:

- 1- Critical ischemia of the target limb, defined by pain at rest and an ankle systolic
pressure < 50 mm Hg, or a toe systolic pressure < 30 mm Hg 2- DFU clinically infected
as defined by the IDSA/IWGDF criteria, osteomyelitis confirmed by MRI, or other
evidence of infection is present 3- Surgery or surgical revascularisation < 2months 4-
Collagen tissue diseases , malignant and hematological diseases onset of myocardial
infarction or cerebral infarction within the last 6 months