Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDilara CANBAY OZDEMIR
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Dexpanthenol
DrugDexpanthenol 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.
Standard Wound Care
Other interventionStandard wound care includes wound cleansing with saline solution and topical wound management according to institutional protocols.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline (Day 0) to Day 19 ±1 and Day 26 ±1Secondary outcomes
1
Change in Wound Epithelialization Percentage
Wound epithelialization will be assessed as the percentage of epithelial tissue covering the wound surface. Changes in epithelialization percentage over time will be evaluated using standardized wound bed tissue composition assessments.
Time frame
Baseline (Day 0) to Day 19 ±1 and Day 26 ±12
Time to Complete Epithelialization
Time to complete epithelialization will be defined as the number of days from baseline to the first visit at which the wound shows complete epithelial coverage without drainage, confirmed at two consecutive follow-up visits.
Time frame
Up to approximately 26 days3
Wound Bed Tissue Composition
Wound bed tissue composition, including percentages of epithelial tissue, granulation tissue, and fibrin or necrotic tissue, will be assessed at each study visit using standardized clinical evaluation methods.
Time frame
Baseline (Day 0) to Day 26 ±14
Local Injection Site Reactions and Adverse Events
Safety outcomes will include the assessment of local injection site reactions such as pain, erythema, edema, induration, and nodule formation, as well as the occurrence of any other adverse events recorded throughout the study period.
Time frame
Baseline (Day 0) to Day 26 ±1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dilara CANBAY OZDEMIR
Lead sponsor
Ordu University
Sponsor institution
Source ClinicalTrials.gov
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