Diabetic Foot UlcerDFUNCT07139964
High-Dose Vitamin D3 for Diabetic Foot Ulcer Healing: Randomized Controlled Trial
A study testing Vitamin D3 in people with Diabetic Foot Ulcer and Vitamin D Deficiency, run by Universitas Sriwijaya at 1 site in Indonesia.
Trial summary
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of high-dose vitamin D3 supplementation in improving diabetic foot ulcer (DFU) healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Vitamin D Deficiency, Wound Healing Disorder
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosis of diabetic foot ulcer (DFU) Serum 25-hydroxyvitamin D level < 30 ng/mL Willingness and ability to provide written informed consent Ability to comply with study procedures and follow-up visits
Who cannot join
- Currently undergoing cancer treatment Pregnant or breastfeeding Current use of vitamin D supplementation History of autoimmune disease Chronic kidney disease with estimated GFR < 30 mL/min/1.73 m² Abnormal liver function tests (AST or ALT ≥ 3× upper normal limit) Ankle-brachial index (ABI) < 0.4 Presence of osteomyelitis Proven sepsis Allergy to vitamin D3 Amputation prior to randomization Withdrawal of consent during the study
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Mohammad Hoesin General Hospital
Palembang, South Sumatra
About this study
Official title: Effectiveness of High-Dose Vitamin D3 in Improving Diabetic Foot Ulcer Healing by Reducing the MMP-9 to TIMP-1 Ratio: Randomized Double-Blind Placebo-Controlled Trial
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of high-dose vitamin D3 supplementation in improving diabetic foot ulcer (DFU) healing. DFUs are common, serious complications of diabetes, often associated with delayed wound healing due to persistent inflammation, impaired angiogenesis, and imbalances between matrix metalloproteinase-9 (MMP-9) and its tissue inhibitor (TIMP-1). Vitamin D deficiency is prevalent among DFU patients and is linked to impaired fibroblast function, poor angiogenesis, and increased inflammation.
Participants with DFUs and serum vitamin D levels <30 ng/mL will be randomized to receive either 10,000 IU oral vitamin D3 daily or placebo for 28 days, in addition to standard DFU care. Primary outcomes include changes in tissue MMP-9/TIMP-1 expression ratio and wound healing progression. The study will provide evidence on whether high-dose vitamin D3 can serve as a safe, effective adjunctive therapy in DFU management.
Read the detailed description
Diabetic foot ulcers are a prevalent and serious complication of uncontrolled diabetes, with a significant proportion leading to infection, amputation, and mortality. Delayed wound healing in DFUs is often driven by prolonged inflammation, persistent infection, impaired angiogenesis, and an imbalance between extracellular matrix (ECM) degradation by MMP-9 and inhibition by TIMP-1. Elevated MMP-9 levels disrupt keratinocyte migration, collagen deposition, and epithelial regeneration, while reduced TIMP-1 further compromises healing.
Vitamin D plays a regulatory role in immune modulation, inflammation control, fibroblast activity, and angiogenesis. Observational and interventional studies have shown that vitamin D deficiency is common in DFU patients and is associated with slower healing. Supplementation has been linked to improved wound healing, reduced inflammatory markers, and better microcirculation. Vitamin D may also modulate MMP-9 and TIMP-1 expression, thereby restoring ECM balance.
This study is a double-blind, placebo-controlled, randomized controlled trial conducted at Dr. Mohammad Hoesin General Hospital, Palembang. Eligible participants are adults with DFUs, low serum vitamin D (<30 ng/mL), and no exclusion criteria such as advanced kidney disease, severe liver disease, osteomyelitis, or sepsis. Participants will be randomized into two groups:
Intervention group: Oral vitamin D3, 10,000 IU daily for 28 days Control group: Placebo daily for 28 days Both groups will receive standard DFU care. Compliance will be monitored with the MMAS-8 scale. Primary outcomes are changes in tissue MMP-9 and TIMP-1 expression (assessed by immunohistochemistry) and wound healing parameters. Secondary outcomes include changes in serum vitamin D levels and correlation between vitamin D status and wound healing outcomes.
The study aims to determine whether high-dose vitamin D3 supplementation reduces the MMP-9/TIMP-1 ratio and accelerates wound healing, potentially supporting its use as a standard adjunctive therapy for DFUs.
- Being tested
- Vitamin D3, Placebo
- Keywords
- Diabetic foot ulcer, Vitamin D3 supplementation
- Medical subject headings
- Diabetic Foot, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called Cholecalciferol
Participants receive oral vitamin D3 (cholecalciferol) 10,000 IU daily for 28 consecutive days, in addition to standard diabetic foot ulcer care according to hospital protocols. Vitamin D3 is provided in identical-appearing capsules. Compliance is monitored using the MMAS-8 adherence scale.
PlaceboOther
Also called Inert capsule
Participants receive an oral placebo capsule daily for 28 consecutive days, in addition to standard diabetic foot ulcer care according to hospital protocols. The placebo is identical in appearance to the vitamin D3 capsule. Compliance is monitored using the MMAS-8 adherence scale.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: High-dose Vitamin D3 | Experimental | Description: Participants receive oral vitamin D3, 10,000 IU daily for 28 days, plus standard care for diabetic foot ulcers.
Intervention Name: Vitamin D3 (Cholecalciferol) Type: Dietary Supplement Dosage: 10,000 IU daily Duration: 28 days Receives: Dietary Supplement: Vitamin D3 |
| Placebo Comparator: Placebo | Placebo comparator | Description: Participants receive oral placebo daily for 28 days, plus standard care for diabetic foot ulcers.
Intervention Name: Placebo Type: Inactive substance Dosage: Matched placebo daily Duration: 28 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tissue MMP-9/TIMP-1 expression ratio from baseline to Day 28
Ratio of matrix metalloproteinase-9 (MMP-9) to tissue inhibitor of metalloproteinase-1 (TIMP-1) expression in wound tissue, measured using immunohistochemistry from surgical biopsy samples.
Measured: Baseline (Day 0) and after completion of intervention (Day 28)
Secondary outcomes (5)
Change in wound size from baseline to Day 28
Measurement of ulcer area using standardized planimetry software from digital photographs.
Measured: Baseline (Day 0) and Day 28
Change in serum vitamin D3 concentration from baseline to Day 28
Serum 25-hydroxyvitamin D3 level measured by chemiluminescent immunoassay.
Measured: Baseline (Day 0) and Day 28
Change in tissue MMP-9 expression from baseline to Day 28
Immunohistochemical staining score of matrix metalloproteinase-9 in wound biopsy specimens.
Measured: Baseline (Day 0) and Day 28
Change in tissue TIMP-1 expression from baseline to Day 28
Immunohistochemical staining score of tissue inhibitor of metalloproteinase-1 in wound biopsy specimens.
Measured: Baseline (Day 0) and Day 28
Correlation between serum vitamin D3 level and wound healing outcomes
Pearson or Spearman correlation between serum 25-hydroxyvitamin D3 concentration and percentage reduction in ulcer size.
Measured: Baseline (Day 0) to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Jul 2024
- Primary completion31 Jan 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sriwijaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kemas M Dahlan, M.D., Principal investigator, Consultant Vascular Surgeon, Department of Surgery, Dr. Mohammad Hoesin General Hospital Palembang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139964
- Sponsor's protocol ID
- DP.04.03/D.XVIII.6.8/ETIK/106/
- Acronym
- DFU
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shin MH, Lee Y, Kim MK, Lee DH, Chung JH. UV increases skin-derived 1alpha,25-dihydroxyvitamin D3 production, leading to MMP-1 expression by altering the balance of vitamin D and cholesterol synthesis from 7-dehydrocholesterol. J Steroid Biochem Mol Biol. 2019 Dec;195:105449. doi: 10.1016/j.jsbmb.2019.105449. Epub 2019 Aug 27.
PubMed 31470109Luanraksa S, Jindatanmanusan P, Boonsiri T, Nimmanon T, Chaovanalikit T, Arnutti P. An MMP/TIMP ratio scoring system as a potential predictive marker of diabetic foot ulcer healing. J Wound Care. 2018 Dec 2;27(12):849-855. doi: 10.12968/jowc.2018.27.12.849.
PubMed 30557113Kim SH, Baek MS, Yoon DS, Park JS, Yoon BW, Oh BS, Park J, Kim HJ. Vitamin D Inhibits Expression and Activity of Matrix Metalloproteinase in Human Lung Fibroblasts (HFL-1) Cells. Tuberc Respir Dis (Seoul). 2014 Aug;77(2):73-80. doi: 10.4046/trd.2014.77.2.73. Epub 2014 Aug 29.
PubMed 25237378Masood MQ, Khan A, Awan S, Dar F, Naz S, Naureen G, Saghir S, Jabbar A. COMPARISON OF VITAMIN D REPLACEMENT STRATEGIES WITH HIGH-DOSE INTRAMUSCULAR OR ORAL CHOLECALCIFEROL: A PROSPECTIVE INTERVENTION STUDY. Endocr Pract. 2015 Oct;21(10):1125-33. doi: 10.4158/EP15680.OR. Epub 2015 Jul 7.
PubMed 26151421Razzaghi R, Pourbagheri H, Momen-Heravi M, Bahmani F, Shadi J, Soleimani Z, Asemi Z. The effects of vitamin D supplementation on wound healing and metabolic status in patients with diabetic foot ulcer: A randomized, double-blind, placebo-controlled trial. J Diabetes Complications. 2017 Apr;31(4):766-772. doi: 10.1016/j.jdiacomp.2016.06.017. Epub 2016 Jun 23.
PubMed 27363929
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High-Dose Vitamin D3 in Improving Diabetic Foot Ulcer Healing by Reducing the MMP-9 to TIMP-1 Ratio: Randomized Double-Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07139964
- Acronym / sponsor ID
- DFU / DP.04.03/D.XVIII.6.8/ETIK/106/
- Keywords
- Diabetic foot ulcer, Vitamin D3 supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitas SriwijayaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 24 Aug 2025 (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.
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of high-dose vitamin D3 supplementation in improving diabetic foot ulcer (DFU) healing. DFUs are common, serious complications of diabetes, often associated with delayed wound healing due to persistent inflammation, impaired angiogenesis, and imbalances between matrix metalloproteinase-9 (MMP-9) and its tissue inhibitor (TIMP-1). Vitamin D deficiency is prevalent among DFU patients and is linked to impaired fibroblast function, poor angiogenesis, and increased inflammation.
Participants with DFUs and serum vitamin D levels <30 ng/mL will be randomized to receive either 10,000 IU oral vitamin D3 daily or placebo for 28 days, in addition to standard DFU care. Primary outcomes include changes in tissue MMP-9/TIMP-1 expression ratio and wound healing progression. The study will provide evidence on whether high-dose vitamin D3 can serve as a safe, effective adjunctive therapy in DFU management.
Detailed description
Diabetic foot ulcers are a prevalent and serious complication of uncontrolled diabetes, with a significant proportion leading to infection, amputation, and mortality. Delayed wound healing in DFUs is often driven by prolonged inflammation, persistent infection, impaired angiogenesis, and an imbalance between extracellular matrix (ECM) degradation by MMP-9 and inhibition by TIMP-1. Elevated MMP-9 levels disrupt keratinocyte migration, collagen deposition, and epithelial regeneration, while reduced TIMP-1 further compromises healing.
Vitamin D plays a regulatory role in immune modulation, inflammation control, fibroblast activity, and angiogenesis. Observational and interventional studies have shown that vitamin D deficiency is common in DFU patients and is associated with slower healing. Supplementation has been linked to improved wound healing, reduced inflammatory markers, and better microcirculation. Vitamin D may also modulate MMP-9 and TIMP-1 expression, thereby restoring ECM balance.
This study is a double-blind, placebo-controlled, randomized controlled trial conducted at Dr. Mohammad Hoesin General Hospital, Palembang. Eligible participants are adults with DFUs, low serum vitamin D (<30 ng/mL), and no exclusion criteria such as advanced kidney disease, severe liver disease, osteomyelitis, or sepsis. Participants will be randomized into two groups:
Intervention group: Oral vitamin D3, 10,000 IU daily for 28 days Control group: Placebo daily for 28 days Both groups will receive standard DFU care. Compliance will be monitored with the MMAS-8 scale. Primary outcomes are changes in tissue MMP-9 and TIMP-1 expression (assessed by immunohistochemistry) and wound healing parameters. Secondary outcomes include changes in serum vitamin D levels and correlation between vitamin D status and wound healing outcomes.
The study aims to determine whether high-dose vitamin D3 supplementation reduces the MMP-9/TIMP-1 ratio and accelerates wound healing, potentially supporting its use as a standard adjunctive therapy for DFUs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: High-dose Vitamin D3 | Experimental | Dietary Supplement: Vitamin D3Description: Participants receive oral vitamin D3, 10,000 IU daily for 28 days, plus standard care for diabetic foot ulcers. Intervention Name: Vitamin D3 (Cholecalciferol) Type: Dietary Supplement Dosage: 10,000 IU daily Duration: 28 days |
| Placebo Comparator: Placebo | Placebo comparator | Other: PlaceboDescription: Participants receive oral placebo daily for 28 days, plus standard care for diabetic foot ulcers. Intervention Name: Placebo Type: Inactive substance Dosage: Matched placebo daily Duration: 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of diabetic foot ulcer (DFU) Serum 25-hydroxyvitamin D level < 30 ng/mL Willingness and ability to provide written informed consent Ability to comply with study procedures and follow-up visits
Key exclusion criteria (1 listed)
- Currently undergoing cancer treatment Pregnant or breastfeeding Current use of vitamin D supplementation History of autoimmune disease Chronic kidney disease with estimated GFR < 30 mL/min/1.73 m² Abnormal liver function tests (AST or ALT ≥ 3× upper normal limit) Ankle-brachial index (ABI) < 0.4 Presence of osteomyelitis Proven sepsis Allergy to vitamin D3 Amputation prior to randomization Withdrawal of consent during the study
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 |
|---|---|---|
| Vitamin D3Also: CholecalciferolParticipants receive oral vitamin D3 (cholecalciferol) 10,000 IU daily for 28 consecutive days, in addition to standard diabetic foot ulcer care according to hospital protocols. Vitamin D3 is provided in identical-appearing capsules. Compliance is monitored using the MMAS-8 adherence scale. | Dietary supplement | Experimental: High-dose Vitamin D3 |
| PlaceboAlso: Inert capsuleParticipants receive an oral placebo capsule daily for 28 consecutive days, in addition to standard diabetic foot ulcer care according to hospital protocols. The placebo is identical in appearance to the vitamin D3 capsule. Compliance is monitored using the MMAS-8 adherence scale. | Other | Placebo Comparator: Placebo |
Primary outcome
Change in tissue MMP-9/TIMP-1 expression ratio from baseline to Day 28
Time frame: Baseline (Day 0) and after completion of intervention (Day 28)
Ratio of matrix metalloproteinase-9 (MMP-9) to tissue inhibitor of metalloproteinase-1 (TIMP-1) expression in wound tissue, measured using immunohistochemistry from surgical biopsy samples.
5 secondary outcomes
Change in wound size from baseline to Day 28
Time frame: Baseline (Day 0) and Day 28
Change in serum vitamin D3 concentration from baseline to Day 28
Time frame: Baseline (Day 0) and Day 28
Change in tissue MMP-9 expression from baseline to Day 28
Time frame: Baseline (Day 0) and Day 28
Change in tissue TIMP-1 expression from baseline to Day 28
Time frame: Baseline (Day 0) and Day 28
Correlation between serum vitamin D3 level and wound healing outcomes
Time frame: Baseline (Day 0) to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Results publication: PubMed 31470109Shin MH, Lee Y, Kim MK, Lee DH, Chung JH. UV increases skin-derived 1alpha,25-dihydroxyvitamin D3 production, leading to MMP-1 expression by altering the balance of vitamin D and cholesterol synthesis from 7-dehydrocholesterol. J Steroid Biochem Mol Biol. 2019 Dec;195:105449. doi: 10.1016/j.jsbmb.2019.105449. Epub 2019 Aug 27.
- Results publication: PubMed 30557113Luanraksa S, Jindatanmanusan P, Boonsiri T, Nimmanon T, Chaovanalikit T, Arnutti P. An MMP/TIMP ratio scoring system as a potential predictive marker of diabetic foot ulcer healing. J Wound Care. 2018 Dec 2;27(12):849-855. doi: 10.12968/jowc.2018.27.12.849.
- Results publication: PubMed 25237378Kim SH, Baek MS, Yoon DS, Park JS, Yoon BW, Oh BS, Park J, Kim HJ. Vitamin D Inhibits Expression and Activity of Matrix Metalloproteinase in Human Lung Fibroblasts (HFL-1) Cells. Tuberc Respir Dis (Seoul). 2014 Aug;77(2):73-80. doi: 10.4046/trd.2014.77.2.73. Epub 2014 Aug 29.
- Results publication: PubMed 26151421Masood MQ, Khan A, Awan S, Dar F, Naz S, Naureen G, Saghir S, Jabbar A. COMPARISON OF VITAMIN D REPLACEMENT STRATEGIES WITH HIGH-DOSE INTRAMUSCULAR OR ORAL CHOLECALCIFEROL: A PROSPECTIVE INTERVENTION STUDY. Endocr Pract. 2015 Oct;21(10):1125-33. doi: 10.4158/EP15680.OR. Epub 2015 Jul 7.
- Results publication: PubMed 27363929Razzaghi R, Pourbagheri H, Momen-Heravi M, Bahmani F, Shadi J, Soleimani Z, Asemi Z. The effects of vitamin D supplementation on wound healing and metabolic status in patients with diabetic foot ulcer: A randomized, double-blind, placebo-controlled trial. J Diabetes Complications. 2017 Apr;31(4):766-772. doi: 10.1016/j.jdiacomp.2016.06.017. Epub 2016 Jun 23.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kemas M Dahlan, M.D. principal investigator
Consultant Vascular Surgeon, Department of Surgery, Dr. Mohammad Hoesin General Hospital Palembang
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Diabetic Foot Ulcer and Vitamin D Deficiency, run by Universitas Sriwijaya at 1 site in Indonesia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Aug 2025. 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 Indonesia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tissue MMP-9/TIMP-1 expression ratio from baseline to Day 28 (time frame: Baseline (Day 0) and after completion of intervention (Day 28)). 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 NCT07139964, which also lists 5 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 24 Aug 2025.