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

The use of human stromal vascular fraction(SVF) and platelet-rich plasma(PRP) in treatment of therapy-resistant diabetic foot ulcers: a randomized control trial phase III

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130811014330N9
Enrollment
20
Registered
2023-09-25
Start date
2023-08-23
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic foot ulcer. Personal history of diabetic foot ulcer

Interventions

Intervention 1: Control group: As the control group, the common treatment for the patient is considered. The common treatment for these patients is a combined treatment including surgery, infection co

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Reza Rahimi

Mashhad University of Medical Sciences

rahimi@mums.ac.ir+98 51 1800 2288

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026