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

Diabetic Foot Ulcers Clinical Trial

Official title:

A Randomized, Double-Blind, Parallel-group, Clinical Trial to Evaluate the Effect of Platelet-Rich Plasma-Fibrin Glue in Combination With Vitamin E and C for Treatment of Non-healing Diabetic Foot Ulcers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04315909
• Other study ID #: IR.MUMS.REC.1398.125
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 28, 2019
• Est. completion date: June 23, 2020

Study information

• Verified date: March 2020
• Source: Mashhad University of Medical Sciences
• Contact: Daryoush Hamidi Alamdari, Ph.D
• Phone: +98 51 3882 8574
• Email: hamidiad[@]mums.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 23, 2020
• Est. primary completion date: June 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Diabetic Wound
• Foot Ulcer
• Ulcer

Intervention

Drug:
• PRP-Fibrin Glue
Platelet-Rich Plasma-Fibrin Glue

Dietary Supplement:
• Vitamin E and C
Vitamin E and vitamin C

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Alavi Hospital	Mashhad	Razavi Khorasan

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing rate of the ulcer	Examination by a vascular surgery physician and documentation	2 months
Primary	Wound Size	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.	2 months
Secondary	Serum ESR at baseline and after the intervention	Erythrocyte Sedimentation Rate	2 months
Secondary	Serum hs-CRP at baseline and after the intervention	high-sensitivity C-Reactive Protein	2 months
Secondary	FBS at baseline and after the intervention	Fasting blood sugar	2 months
Secondary	HbA1c at baseline and after the intervention	Glycated hemoglobin	2 months
Secondary	Lipid Profile at baseline and after the intervention	Serum Triglyceride, Cholesterol, HDL, LDL, VLDL	2 months
Secondary	Serum Urea at baseline and after the intervention	In a quantitative laboratory method	2 months
Secondary	Serum Creatinine at baseline and after the intervention	In a quantitative laboratory method	2 months
Secondary	Serum total bilirubin at baseline and after the intervention	In a quantitative laboratory method	2 months
Secondary	Serum Uric acid at baseline and after the intervention	In a quantitative laboratory method	2 months
Secondary	Serum Homocysteine at baseline and after the intervention	In a quantitative laboratory method	2 months
Secondary	Pro-Oxidant Antioxidant Balance at baseline and after the intervention	The PAB assay is a test to determine the oxidants and antioxidants simultaneously in one single test.	2 months