The Effect of Platelet-Rich Plasma-Fibrin Glue in Combination With Vitamin E and C for Treatment of Non-healing Diabetic Foot Ulcers

Mashhad University of Medical Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Diabetic Foot Ulcers; Diabetic Wound

Treatments: Dietary Supplement: Vitamin E and C; Drug: PRP-Fibrin Glue; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04315909

IR.MUMS.REC.1398.125

Details and patient eligibility

About

The aim of this study is to evaluates the chance of non-healing Diabetic Foot Ulcers repair by reducing oxidative stress caused by diabetes by taking vitamin E and C supplements along with the use of Platelet-Rich Plasma-Fibrin Glue as an effective treatment for wound healing.

Enrollment: 24 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. DFU is classified as Wagner 1 -2 on the Wagner classification system.
2. Persons with type 1 or type 2 diabetes with a non-healing ulcer of at least 4 weeks duration.
3. If more than one non-healing wound is present, the largest of the wounds that is classified as a Wagner 1- 2.
4. The index ulcer had to be clinically non-infected.
5. Ankle Brachial Index (ABI) greater than or equal to 0.7.
6. HemoglobinA1C (HbA1c) < 12
7. Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces).
8. Wound area (length x width) measurement between 2 cm2 and 20 cm2.
9. Non-use of drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents.
10. No smoking, alcohol or drug addiction.
11. Approved, informed, signed consent.

Exclusion criteria

1. Previous consumption of vitamin E and C supplements.
2. Index ulcer has exposed tendons, ligaments, muscle, or bone.
3. Confirmed presence of osteomyelitis, or if osteomyelitis is suspected.
4. Patients with renal deficiency, hepatic failure, has known immune insufficiency and cancer.
5. Subject is pregnant or plans to become pregnant during the duration of the trial.
6. Patient's blood vessels are non-compressible for ABI testing.
7. Patient is known to have a psychological, developmental, physical, emotional disorders.
8. Received systemic corticosteroids or immunosuppressive agents.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

24 participants in 2 patient groups

Intervention group

Experimental group

Description:

Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus vitamin supplements (E (200 IU/ 2day) and C (250 mg/ 2day) ) for 8 weeks.

Treatment:

Drug: PRP-Fibrin Glue

Dietary Supplement: Vitamin E and C

Control group

Experimental group

Description:

Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus placebo for 8 weeks.

Treatment:

Other: Placebo

Drug: PRP-Fibrin Glue