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

Phase 2

• Conditions: Diabetic Wound; Diabetic Foot Ulcers
• Interventions: Drug: PRP-Fibrin Glue; Dietary Supplement: Vitamin E and C; Other: Placebo

• Registration Number: NCT04315909
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-28
• Status Verified: 2020-03
• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-18
• Last Update Submitted: 2020-03-18
• Study First Posted: 2020-03-20
• Last Update Posted: 2020-03-20
• Primary Completion: 2020-06-23
• Study Completion: 2020-06-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	PRP-Fibrin Glue	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.
Intervention group	Vitamin E and C	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.
Control group	PRP-Fibrin Glue	Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus placebo for 8 weeks.
Control group	Placebo	Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus placebo for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Healing rate of the ulcer	2 months	Examination by a vascular surgery physician and documentation
Wound Size	2 months	Wound size will be measured with ruler for length, width as well as with digital imaging. Wound size will be assessed in digital images taken of the wound.

Secondary Outcome Measures

Name	Time	Method
Serum ESR at baseline and after the intervention	2 months	Erythrocyte Sedimentation Rate
Serum hs-CRP at baseline and after the intervention	2 months	high-sensitivity C-Reactive Protein
HbA1c at baseline and after the intervention	2 months	Glycated hemoglobin
Serum Urea at baseline and after the intervention	2 months	In a quantitative laboratory method
Serum total bilirubin at baseline and after the intervention	2 months	In a quantitative laboratory method
Serum Uric acid at baseline and after the intervention	2 months	In a quantitative laboratory method
FBS at baseline and after the intervention	2 months	Fasting blood sugar
Lipid Profile at baseline and after the intervention	2 months	Serum Triglyceride, Cholesterol, HDL, LDL, VLDL
Serum Creatinine at baseline and after the intervention	2 months	In a quantitative laboratory method
Serum Homocysteine at baseline and after the intervention	2 months	In a quantitative laboratory method
Pro-Oxidant Antioxidant Balance at baseline and after the intervention	2 months	The PAB assay is a test to determine the oxidants and antioxidants simultaneously in one single test.

Trial Locations

Locations (1)

Alavi Hospital; 🇮🇷 Mashhad, Razavi Khorasan, Iran, Islamic Republic of