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

Last updated: March 18, 2020
Sponsor: Mashhad University of Medical Sciences
Overall Status: Active - Recruiting

Phase

2/3

Condition

Diabetic Foot Ulcers

Ulcers

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT04315909
IR.MUMS.REC.1398.125
  • Ages 35-75
  • All Genders

Study 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

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 weeksduration.

  3. If more than one non-healing wound is present, the largest of the wounds that isclassified 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

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 andcancer.

  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, emotionaldisorders.

  8. Received systemic corticosteroids or immunosuppressive agents.

Study Design

Total Participants: 24
Study Start date:
August 28, 2019
Estimated Completion Date:
June 23, 2020

Connect with a study center

  • Alavi Hospital

    Mashhad, Razavi Khorasan 9137913316
    Iran, Islamic Republic of

    Active - Recruiting

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