Evaluation of efficacy of local injection of mesenchymal stem cells for the treatment of neuropathic diabetic foot ulcer
Phase 3
Recruiting
- Conditions
- Condition 1: Treatment of chronic neuropathic diabetic foot ulcers. Condition 2: Treatment of chronic neuropathic diabetic foot ulcers. Condition 3: Treatment of chronic neuropathic diabetic foot ulcers.Type 2 diabetes mellitus with foot ulcerType 1 diabetes mellitus with foot ulcerType 2 diabetes mellitus with diabetic neuropathy, unspecifiedE11.622E10.621E11-40
- Registration Number
- IRCT20180619040147N5
- Lead Sponsor
- Iranian academic center for education culture and research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Chronic diabetic ulcers (more than 6 weeks) grade I-II Wagner classification without osteomyelitis
Full thickness ulcer
The size of the wound has to be between1-8 cm2
Controlled blood sugar (HbA1c less than 10)
Patient's consent and clarification on whether they may be concluded in control or treatment group
Non responsive ulcers to previous medications and treatments
Exclusion Criteria
Ulcers that are classified as grade 3-4 of Wagner classification or osteomyelitis has occurred
Patients that don't meet the age criteria of the study
High blood sugar levels
The wounds that do not include full layers of skin.
The wounds healed by other standard diabetic ulcers treatment methods
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Full thickness closure progress. Timepoint: Before treatment, the first, second, fourth, fifth, and sixth weeks and again on third, fourth, fifth, and sixth-months post-treatment. Method of measurement: On each evaluation period, the wounds will be measured with special devices like a ruler specialized for wound measurements.
- Secondary Outcome Measures
Name Time Method