Subcutaneous Dexpanthenol Administration and Wound Epithelialization

Chronic wounds, including diabetic foot ulcers, venous leg ulcers, and arterial ulcers, represent a major clinical challenge due to delayed healing, increased risk of complications, and reduced quality of life. Impaired epithelialization, prolonged inflammation, and insufficient tissue regeneration are key mechanisms contributing to non-healing wounds. Therefore, interventions that support epithelial repair and wound closure may improve clinical outcomes when added to standard wound care.

Dexpanthenol, a provitamin B5 derivative, is converted to pantothenic acid and plays an essential role in coenzyme A metabolism, which is involved in cellular energy production and tissue repair. Experimental and clinical studies have suggested that dexpanthenol may enhance fibroblast activity, epithelialization, and skin barrier restoration. Injectable formulations of dexpanthenol are approved for clinical use; however, data on subcutaneous administration for chronic wound healing are limited.

This study is designed as a randomized, open-label, controlled clinical trial to evaluate the effect of subcutaneous dexpanthenol administration on wound epithelialization when added to standard wound care. Adult patients with non-infected chronic wounds, including diabetic foot ulcers, venous leg ulcers, and arterial ulcers, will be enrolled. Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group using computer-generated block randomization.

Participants in the intervention group will receive standard wound care plus perilesional subcutaneous dexpanthenol injections administered at predefined intervals. The dose and injection volume will be standardized according to wound size, and a limited number of treatment sessions will be applied. Participants in the control group will receive standardized wound care alone. Both groups will follow the same visit schedule and assessment procedures throughout the study period.

Wound healing will be evaluated using objective and standardized methods. The primary outcome is the percentage change in wound area from baseline to follow-up visits. Secondary outcomes include changes in epithelialization percentage, time to complete epithelialization, wound bed tissue composition, and safety outcomes. Safety assessments will focus on local injection-site reactions and the occurrence of any adverse events, which will be systematically recorded during each visit.

This study aims to provide structured clinical data on the feasibility, safety, and potential clinical benefit of subcutaneous dexpanthenol as an adjunctive treatment in chronic wound management. The findings are expected to contribute to future studies and inform the design of larger-scale clinical trials in this field.

Inclusion criteria

• Adults aged 18 years and older.
• Presence of a chronic wound, including diabetic foot ulcer, venous leg ulcer, or arterial ulcer.
• Target wound size between 1 and 20 cm² at baseline.
• Non-infected wound, defined by the absence of purulent discharge, foul odor, spreading erythema, cellulitis, or systemic signs of infection.
• Clinically stable patients without the need for systemic antibiotic therapy.
• Ability to understand the study procedures and provide written informed consent.
• Willingness and ability to comply with study visits and treatment schedule.

Exclusion criteria

• Clinical signs of wound infection or requirement for systemic antibiotic treatment.
• Critical limb ischemia, defined as ankle-brachial index <0.5, rest pain, gangrene, or extensive tissue necrosis.
• Wounds exposing bone, tendon, or joint structures, or suspected osteomyelitis.
• Wound size smaller than 1 cm² or larger than 20 cm².
• Malignant, autoimmune, vasculitic, or specific dermatologic conditions causing the wound.
• Known hypersensitivity or allergy to dexpanthenol or any component of the study treatments.
• Pregnancy or breastfeeding.
• Cognitive impairment or inability to provide informed consent.
• Participation in another interventional clinical trial that could interfere with the outcomes of this study.
• Any medical condition that, in the investigator's judgment, could compromise participant safety or study integrity.