Human stromal vascular fraction(SVF) and platelet-rich plasma(PRP) in treatment of therapy-resistant diabetic foot ulcers

Phase 3

Recruiting

Conditions: Diabetic foot ulcer.
Personal history of diabetic foot ulcer
Z86.31

Registration Number: IRCT20130811014330N9

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

Having a diabetic ulcer grade 1 to 4 according to Wagner's classification
Having a single wound in the legs and extremities (fingers, soles, heels, on the toes) that has been at least 4 weeks old
No smoking, alcohol and drug addiction
Not taking drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents
Not having concurrent diseases such as cancers, vasculitis, kidney and liver failure, and heart failure that may cause problems in wound healing
Informed consent of patients

Exclusion Criteria

Patients with acute bone inflammation or osteomyelitis
A wound with visible bone in the target area of treatment
Infected diabetic foot ulcers
Charcot deformity
History of treatment with chemotherapy drugs or radiation therapy in 3 months before the start of treatment
Hemoglobin less than 10mg/dL
History of treatment with growth factors during two weeks before starting treatment
Patients with less than 100,000 platelets
Vascular problems should not be observed in the wound (not ABI?0.7)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The size of the wound. Timepoint: before dressing and after dressing in the first, second, third, and fourth week after treatment and then in the second, fourth, and sixth months after intervention. Method of measurement: Digital photographic camera, sterile metal ruler.;Wound depth. Timepoint: before dressing and after dressing in the first, second, third, and fourth week after treatment and then in the second, fourth, and sixth months after intervention. Method of measurement: Sterile metal measuring cup.

Secondary Outcome Measures

Name	Time	Method
Stress oxidative markers. Timepoint: 6 Months after intervention. Method of measurement: Gene expression level by Real time PCR.;Angiogenesis and inflammation markers. Timepoint: 6 Months after intervention. Method of measurement: Gene expression level by Real time PCR.;MiRNA levels in serum of peripheral blood. Timepoint: 6 Months after intervention. Method of measurement: Gene expression level by Real time PCR.