Clinical trial NCT04315909: The Effect of Platelet-Rich Plasma-Fibrin Glue in Combination With Vitamin E and C for Treatment of Non-healing Diabetic Foot Ulcers
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Diabetic Foot Ulcers
Diabetic Wound
Keywords: Platelet-Rich Plasma-Fibrin Glue
DFU
Vitamin E
Vitamin C
non-healing Diabetic Foot Ulcers
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Healing rate of the ulcer
timeFrame: 2 months
measure: Wound Size
timeFrame: 2 months
Secondary outcomes:
measure: Serum ESR at baseline and after the intervention
timeFrame: 2 months
measure: Serum hs-CRP at baseline and after the intervention
timeFrame: 2 months
measure: FBS at baseline and after the intervention
timeFrame: 2 months
measure: HbA1c at baseline and after the intervention
timeFrame: 2 months
measure: Lipid Profile at baseline and after the intervention
timeFrame: 2 months
measure: Serum Urea at baseline and after the intervention
timeFrame: 2 months
measure: Serum Creatinine at baseline and after the intervention
timeFrame: 2 months
measure: Serum total bilirubin at baseline and after the intervention
timeFrame: 2 months
measure: Serum Uric acid at baseline and after the intervention
timeFrame: 2 months
measure: Serum Homocysteine at baseline and after the intervention
timeFrame: 2 months
measure: Pro-Oxidant Antioxidant Balance at baseline and after the intervention
timeFrame: 2 months
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Alavi Hospital
state: Razavi Khorasan
Study officials:
affiliation: Mashhad University of Medical Sciences, Mashhad, Iran
name: Daryoush Hamidi Alamdari, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yarahmadi A, Saeed Modaghegh MH, Mostafavi-Pour Z, Azarpira N, Mousavian A, Bonakdaran S, Jarahi L, Samadi A, Peimani M, Hamidi Alamdari D. The effect of platelet-rich plasma-fibrin glue dressing in combination with oral vitamin E and C for treatment of non-healing diabetic foot ulcers: a randomized, double-blind, parallel-group, clinical trial. Expert Opin Biol Ther. 2021 May;21(5):687-696. doi: 10.1080/14712598.2021.1897100. Epub 2021 Apr 13.