Subcutaneous Dexpanthenol Administration and Wound Epithelialization

NCT07395674 | Not Yet Recruiting

• 1 other identifier: OU-FM-Dexpanthenol-2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic wounds are wounds that do not heal properly over time and can significantly reduce quality of life. Common types include diabetic foot ulcers, venous leg ulcers, and arterial ulcers. Improving wound healing and speeding up skin regeneration (epithelialization) are important goals in the care of these patients. Dexpanthenol is a vitamin B5 derivative that supports skin repair and tissue regeneration. It is widely used in topical treatments, and injectable forms are approved for clinical use. However, the effects of subcutaneous (under the skin) dexpanthenol injections on chronic wound healing have not been sufficiently studied in clinical settings. The purpose of this study is to evaluate whether adding subcutaneous dexpanthenol injections to standard wound care improves wound healing compared with standard wound care alone. Adult patients with non-infected chronic wounds will be randomly assigned to one of two groups. One group will receive standard wound care only, while the other group will receive standard wound care plus subcutaneous dexpanthenol injections around the wound area. Wound healing will be assessed by measuring changes in wound size and the degree of skin epithelialization over time using standardized and objective methods. Safety will be monitored by recording local reactions at the injection site and any other adverse events during the study. The results of this study may provide preliminary clinical evidence on the effectiveness and safety of subcutaneous dexpanthenol as an additional treatment option for chronic wound management.

Conditions

Chronic Wounds; Diabetic Foot Ulcer; Venous Leg Ulcers; Arterial Ulcer

Keywords

Dexpanthenol; Chronic Wounds; Wound Healing; Epithelialization; Diabetic Foot Ulcer; Venous Leg Ulcer; Arterial Ulcer; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Wound Area

  The primary outcome measure is the percentage change in wound area from baseline. Wound area will be calculated using standardized ruler-based measurements of the longest length and widest width of the wound and applying an elliptical area formula. The percentage change in wound area will be calculated by comparing baseline measurements with follow-up measurements.

  Baseline (Day 0) to Day 19 ±1 and Day 26 ±1

Secondary Outcomes (4)

• Change in Wound Epithelialization Percentage

  Baseline (Day 0) to Day 19 ±1 and Day 26 ±1

• Time to Complete Epithelialization

  Up to approximately 26 days

• Wound Bed Tissue Composition

  Baseline (Day 0) to Day 26 ±1

• Local Injection Site Reactions and Adverse Events

  Baseline (Day 0) to Day 26 ±1

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in this group will receive standard wound care plus perilesional subcutaneous dexpanthenol injections administered at predefined intervals according to a standardized protocol.

Drug: Dexpanthenol; Other: Standard Wound Care

Control Group

ACTIVE COMPARATOR

Participants in this group will receive standardized wound care alone without subcutaneous dexpanthenol administration.

Other: Standard Wound Care

Interventions

Dexpanthenol DRUG

Dexpanthenol will be administered by perilesional subcutaneous injection around the wound area in addition to standard wound care. The injection dose and volume will be standardized according to wound size, with a limited number of treatment sessions.

Intervention Group

Standard Wound Care OTHER

Standard wound care includes wound cleansing with saline solution and topical wound management according to institutional protocols.

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dilara CANBAY OZDEMIR: lead

Study Sites (1)

Ordu University Training and Research Hospital

Ordu, Ordu, 52200, Turkey (Türkiye)

Location

Related Publications (4)

• Heise R, Skazik C, Marquardt Y, Czaja K, Sebastian K, Kurschat P, Gan L, Denecke B, Ekanayake-Bohlig S, Wilhelm KP, Merk HF, Baron JM. Dexpanthenol modulates gene expression in skin wound healing in vivo. Skin Pharmacol Physiol. 2012;25(5):241-8. doi: 10.1159/000341144. Epub 2012 Jun 29.

  PMID: 22759998 BACKGROUND

• Proksch E, de Bony R, Trapp S, Boudon S. Topical use of dexpanthenol: a 70th anniversary article. J Dermatolog Treat. 2017 Dec;28(8):766-773. doi: 10.1080/09546634.2017.1325310. Epub 2017 May 14.

  PMID: 28503966 BACKGROUND

• Gorski J, Proksch E, Baron JM, Schmid D, Zhang L. Dexpanthenol in Wound Healing after Medical and Cosmetic Interventions (Postprocedure Wound Healing). Pharmaceuticals (Basel). 2020 Jun 29;13(7):138. doi: 10.3390/ph13070138.

  PMID: 32610604 BACKGROUND

• Metin N, Karapinar T, Turan C. Lip mesotherapy with dexpanthenol in the treatment of isotretinoin-induced cheilitis. J Cosmet Dermatol. 2022 Oct;21(10):4684-4690. doi: 10.1111/jocd.14993. Epub 2022 May 10.

  PMID: 35426210 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer

Interventions

dexpanthenol

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Study Officials

• Dilara Canbay Özdemir, MD

  Ordu University Faculty of Medicine, Department of Family Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Family Medicine

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group and will remain in their assigned group throughout the study. Both groups will be followed in parallel according to the same visit schedule and assessment procedures.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start (Estimated): August 2, 2026
• Primary Completion (Estimated): August 2, 2028
• Study Completion (Estimated): December 2, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)