Chronic WoundsDEXPAN-WOUNDNCT07395674
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
A study testing Dexpanthenol and Standard Wound Care in people with Chronic Wounds and Diabetic Foot Ulcer, run by Dilara CANBAY OZDEMIR at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Wounds, Diabetic Foot Ulcer, Venous Leg Ulcers
- What is being tested?
- Dexpanthenol and Standard Wound Care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2026to 2 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ordu University Training and Research Hospital
Ordu, Ordu, 52200
Dilara Canbay Özdemir, MD, +905388147957, dilaracanbayozdemir@odu.edu.tr
About this study
Official title: Evaluation of the Effect of Subcutaneous Dexpanthenol Administration on Wound Epithelialization: A Pilot Randomized Controlled Study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Chronic Wounds, Diabetic Foot Ulcer, Venous Leg Ulcers, Arterial Ulcer
- Being tested
- Dexpanthenol, Standard Wound Care
- Keywords
- Dexpanthenol, Chronic Wounds, Wound Healing, Epithelialization, Diabetic Foot Ulcer, Venous Leg Ulcer, Arterial Ulcer, Randomized Controlled Trial
- Medical subject headings
- Diabetic Foot, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexpanthenolDrug
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.
Standard Wound CareOther
Standard wound care includes wound cleansing with saline solution and topical wound management according to institutional protocols.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dexpanthenol; Other: Standard Wound Care |
| Control Group | Active comparator | Participants in this group will receive standardized wound care alone without subcutaneous dexpanthenol administration. Receives: Other: Standard Wound Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0) to Day 19 ±1 and Day 26 ±1
Secondary outcomes (4)
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.
Measured: Baseline (Day 0) to Day 19 ±1 and Day 26 ±1
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.
Measured: Up to approximately 26 days
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.
Measured: Baseline (Day 0) to Day 26 ±1
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.
Measured: Baseline (Day 0) to Day 26 ±1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start2 Dec 2026 (estimated)
- Primary completion2 Aug 2028 (estimated)
- Study completion2 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dilara CANBAY OZDEMIR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dilara CANBAY OZDEMIR, Ordu University
- Investigators
- Dilara Canbay Özdemir, MD, Principal investigator, Ordu University Faculty of Medicine, Department of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395674
- Sponsor's protocol ID
- OU-FM-Dexpanthenol-2026
- Acronym
- DEXPAN-WOUND
- Status last verified
- Oct 2026
- First submitted
- 2 Feb 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
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.
PubMed 22759998Proksch 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.
PubMed 28503966Gorski 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.
PubMed 32610604Metin 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.
PubMed 35426210
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Subcutaneous Dexpanthenol Administration on Wound Epithelialization: A Pilot Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07395674
- Acronym / sponsor ID
- DEXPAN-WOUND / OU-FM-Dexpanthenol-2026
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dilara CANBAY OZDEMIRUniversity, hospital or other
- Study start
- 2 Dec 2026 (estimated)
- Primary completion
- 2 Aug 2028 (estimated)
- Study completion
- 2 Dec 2028 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Dexpanthenol, Other: Standard Wound CareParticipants in this group will receive standard wound care plus perilesional subcutaneous dexpanthenol injections administered at predefined intervals according to a standardized protocol. |
| Control Group | Active comparator | Other: Standard Wound CareParticipants in this group will receive standardized wound care alone without subcutaneous dexpanthenol administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexpanthenolDexpanthenol 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. | Drug | Intervention Group |
| Standard Wound CareStandard wound care includes wound cleansing with saline solution and topical wound management according to institutional protocols. | Other | Control Group, Intervention Group |
Primary outcome
Percentage Change in Wound Area
Time frame: Baseline (Day 0) to Day 19 ±1 and Day 26 ±1
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.
4 secondary outcomes
Change in Wound Epithelialization Percentage
Time frame: Baseline (Day 0) to Day 19 ±1 and Day 26 ±1
Time to Complete Epithelialization
Time frame: Up to approximately 26 days
Wound Bed Tissue Composition
Time frame: Baseline (Day 0) to Day 26 ±1
Local Injection Site Reactions and Adverse Events
Time frame: Baseline (Day 0) to Day 26 ±1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 22759998Heise 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.
- Background: PubMed 28503966Proksch 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.
- Background: PubMed 32610604Gorski 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.
- Background: PubMed 35426210Metin 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ordu University Training and Research Hospital
Ordu, Turkey (Türkiye)
Dilara Canbay Özdemir, MD principal investigator
Ordu University Faculty of Medicine, Department of Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexpanthenol and Standard Wound Care in people with Chronic Wounds and Diabetic Foot Ulcer, run by Dilara CANBAY OZDEMIR at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Wound Area (time frame: Baseline (Day 0) to Day 19 ±1 and Day 26 ±1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07395674, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.