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

ABSTRACT

Objective

The current study assesses the effects of platelet-rich plasma-fibrin glue (PRP-FG) dressing along with oral vitamin E and C on wound healing and biochemical markers in patients with non-healing diabetic foot ulcers (non-healing DFU).

Methods

This randomized controlled trial was performed on 25 patients with non-healing DFU. Patients were treated with PRP-FG dressing plus oral vitamin E and C (intervention group) or PRP-FG dressing plus placebo (control group) for 8 weeks.

Results

Eight weeks after treatment, six wounds in the intervention group and two wounds in the control group were completely closed, and also wound size significantly reduced in both intervention and control groups (p < 0.05). This reduction in wound size was significantly greater in the intervention group compared to the control group (p = 0.019). Also, a significant decrease in prooxidant–antioxidant balance (PAB) , ESR, and hs-CRP was observed in the intervention group compared to the control group (p < 0.05).

Conclusion

Our results showed that PRP-FG dressing along with oral vitamin E and C could be used to increase wound healing in patients with non-healing DFU by enhancing the wound healing process and reducing oxidative stress.

Trial Registration

This trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT04315909).

KEYWORDS:

• Diabetes
• non-healing diabetic foot ulcers
• platelet-richplasma-fibrin glue
• vitamin E and C supplementation
• wounds

Acknowledgments

The work described in this manuscript was a part of the dissertation of Amir Yarahmadi, submitted to Mashhad University of Medical Sciences for the Ph.D. in Clinical Biochemistry. The authors gratefully acknowledge all of nurses in diabetes foot clinic of Alavi Hospital. This trial is registered at ClinicalTrials.gov with CT.gov identifier NCT04315909.

Declaration of interest

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Author’s contributions

Amir Yarahmadi, Mohammad-Hadi Saeed Modaghegh, Zohreh Mostafavi-Pour, Negar Azarpira, and Daryoush Hamidi Alamdari all participate in conceptualization, data curation, formal analysis, funding acquisition, investigation, methodology, project administration, resources, software, supervision, validation, visualization, writing-original draft, writing-review & editing. Alireza Mousavian, Alireza Samadi, Meghdad Peimani, and Shokoufeh Bonakdaran all dealt with conceptualization, investigation, methodology, project administration, resources, writing-original draft, writing-review & editing. Lida Jarahi dealt with conceptualization, data curation, formal analysis, funding acquisition, methodology, software, validation, writing-original draft, writing-review & editing. All authors gave the final approval of the version to be published, and all authors agree to be accountable for all aspects of the work.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This work was financially supported by the Research Council at Mashhad University of Medical Sciences under Grant numbers 971193 and 971636.