Investigating the safety and efficacy of stem cell exosomes on diabetic foot ulcers

Phase 1

Recruiting

Conditions: Diabetic Foot Ulcer.
Type 2 diabetes mellitus

Registration Number: IRCT20240317061316N1

Lead Sponsor: Qazvin University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Voluntary participation in the research by complying with the requirements of the protocol and accepting the steps related to its implementation and signing the informed consent form
Age over 30 years and less than 60 years
Suffering from type I or type II diabetes
Diabetic foot ulcer size between 1 cm2 to 12 cm2
Type II or type III wound with Wagner grading and spread to skin, tendon and subcutaneous tissue without evidence of active wound infection at the time of eligibility to participate in the study
Free of necrotic remnants in the target wound
Blood glycosylated hemoglobin level (HbA1c) <=10%
Satisfactory perfusion to the wound as confirmed by measurement of systolic blood pressure in the posterior or anterior tibial artery (>50 mmHg) of the affected limb
General health status, which according to the researcher, allows the patient to participate in all stages of the study

Exclusion Criteria

1. Non-diabetic pathophysiological wound.
2. People who need intravenous (IV) antibiotics to treat infection.
3. Current evidence of infection, including drainage of pus from the wound site.
4. People with severe kidney failure who cannot be managed with kidney dialysis.
5. People with severe liver failure.
6. Human immunodeficiency virus (HIV) positive
7. People who have an allergic reaction or hypersensitivity to natural proteins and polysaccharides.
8. Pregnancy or breastfeeding
9. People with a clinical history related to alcohol or drug abuse.
10. Suffering from a disease that can affect the study.
11. People who have had a history of malignant tumor surgery in the last five years (with the exception of carcinoma in situ).
12. People who are currently enrolled or in another clinical study.
13. People who have undergone wound treatment with growth factors, skin substitutes or other biological treatments in the last 30 days.
14. People who receive oral or injectable corticosteroids, immunosuppressant or cytotoxic drugs with unstable dosage before 4 weeks.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wound closure rate. Timepoint: Wound healing rate after 1, 7, 14, 28, 60. Method of measurement: Wound size is evaluated using a 3D digital wound imaging device with image processing software.

Secondary Outcome Measures

Name	Time	Method
Amputation rate. Timepoint: The amount of amputation after 1, 7, 14, 28 days. Method of measurement: Tissue size.;Skin edema. Timepoint: The amount of skin edema after 1, 7, 14, 28 days. Method of measurement: Reduction of swelling and accumulation of fluids with the weight grading system for skin size results in +1 to +4. It is evaluated by applying pressure on the damaged area and then measuring the depth of the pit (with a ruler) and its duration (return time). Degree of +1 to 2 mm indentation, setting the return time using a timer.;Infection. Timepoint: The rate of infection after 1, 7, 14, 28 days. Method of measurement: Bacterial culture.