Diabetic Foot InfectionsPhase 2/3OLENKRON-01NCT06232421
Clinical Study in Adult Patients With Purulent-inflammatory Processes of the Skin and Soft Tissues, Phase I-II of the Wound Process
A Phase 2/3 study testing Foscelantan and Povidon-iodine in people with Diabetic Foot Infections and Chronic Venous Insufficiency, run by Research Institute for Physical Chemical Problems of the Belarusian State University at 2 sites in Belarus.
Trial summary
The purpose of this study is to estimate efficiency, tolerance, safety of "Foscelantan, medicinal plate 4.0x5.0 cm in package No. 1" among adult patients who have purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome or chronic venous insufficiency, phase… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Foot Infections, Chronic Venous Insufficiency
- What is being tested?
- Foscelantan and Povidon-iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 2 sitesBelarus
- Study dates
- Nov 2025to May 2026
- Phase
- Phase 2/3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The presence of purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome (Main diagnosis: Diabetes mellitus type I or II, clinical metabolic compensation/subcompensation, class I - II according to the Wagner classification) or chronic venous insufficiency (Main diagnosis: Varicose veins dilatation of the veins of the lower extremities, class C6 according to the CEAP classification), phase I-II of the wound process
- The size of the ulcerative defect is from 1 cm² to 20 cm²
- Secondary type of wound healing
- Absence of exposed bones and tendons in the wound
- Absence of severe concomitant diseases in the stage of decompensation, oncological diseases, as well as diseases requiring steroid therapy
- Availability of written informed consent from the patient to participate in the study
- The patient's ability to follow the instructions of the research physician and comply with the study regimen
Who cannot join
- Individual intolerance or hypersensitivity reactions to the components of the drug Foscelantan
- Neuroischemic form of diabetic foot syndrome
- The presence of serious concomitant pathology (severe form of renal and hepatic failure, systemic connective tissue diseases, severe cardiovascular insufficiency), history and current mental illness
- The need to constantly take drugs from the list of prohibited therapies
- Participation of the patient in another clinical trial within 3 months before the current clinical trial
- Acute bleeding
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- Level of peripheral blood leukocytes less than 1.5 × 109 per l, platelets less than 75.0 × 109 per l.
- Hemoglobin less than 80g per l.
- Positive tests for syphilis, human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Severe liver dysfunction - AST or ALT levels exceed the upper limit of normal by 5 times or more, bilirubin ≥ 2.0 mg/dL (34.2 µmol/L).
- Severe renal dysfunction - creatinine 2 times higher than reference values
- Diabetes mellitus in a state of clinical and metabolic decompensation
- Pregnant and breastfeeding women
- At one\'s own request without explaining the reasons for the action.
- At the request of the research physician, if the research subject violates the protocol requirements for diet, consumption of alcoholic beverages, and medications without the prescription of the research physician.
- For reasons independent of the study subject and the research physician, when a study subject develops drug intolerance and other life-threatening or requiring emergency pharmacotherapy adverse reactions to the administration of the study drug.
- The need to prescribe drugs from the list of prohibited treatments.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belarus2 sites
10th CITY CLINICAL HOSPITAL
Minsk, Minsk City, 220096
Viktor Isachkin, +375173419811, info@10gkb.by
Mihail Shkoda, +375447628662, info@10gkb.by
Health care institution Vitebsk Regional Clinical Hospital
Vitebsk, Vitebsk Oblast, 210037
Evgenij Matusevich, +375339901777, info@vokb.by
Uladislau Zjuzenko, +375212689267, info@vokb.by
About this study
Official title: A Prospective, Parallel, Single-blind Clinical Study Using Stratified Randomization of the Effectiveness, Tolerability and Safety of the Medicinal Product "Foscelantan, Medicinal Plate 4.0x5.0 cm in Package No. 1" Produced by UNITEKHPROM BSU, Republic of Belarus, in Comparison With the Medicinal Product Povidone- Iodine Produced by BelAseptika JSC, in Adult Patients With Purulent-inflammatory Processes of the Skin and Soft Tissues Due to the Neuropathic Form of Diabetic Foot Syndrome or Chronic Venous Insufficiency, Phase I-II of the Wound Process
The purpose of this study is to estimate efficiency, tolerance, safety of "Foscelantan, medicinal plate 4.0x5.0 cm in package No. 1" among adult patients who have purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome or chronic venous insufficiency, phase I-II of the wound process.
Read the detailed description
Diabetes takes the third place in the World in terms of its medical and social significance. Diabetes is often complicated with such urulent-inflammatory processe as diabetic foot syndrome. Urulent-inflammatory processes treatment takes a long time and medications due to microcirculation disorders, metabolic disorders, progressive hypoxia and a number of other factors. A moist wound environment, conducive to the natural process of wound cleansing (autolysis), regeneration of damaged tissue, and reduction of pain, irreversible sorption of excess exudate and toxic components and easy removal of the drug from the surface of the wound without additional trauma or damage are yhe main conditions of successful wound healing.Wound dressings made of fibrous polysaccharides modyfied with drugs meet these requirements. Foscelantan has prolonged antimicrobial, analgesic and reparative action, has the ability to transform on the wound surface into an amorphous gel-like mass, irreversibly bind wound detritus and pathological exudate, and provide optimal conditions for the process of wound healing.
- Being tested
- Foscelantan, Povidon-iodine
- Keywords
- diabetic foot infection, chronic venous insuffiency, lidocaine, cellulose, miramistin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoscelantanDrug
"Foscelantan, medicinal plate 4.0x5.0 cm in package No. 1" produced by UNITEHPROM BSU, Republic of Belarus
Povidon-iodineDrug
Povidone-iodine solution 100 mg/ml produced by BelAseptika CJSC, Republic of Belarus
| Study group | Role | What they receive |
|---|---|---|
| Patients with the neuropathic form. Treatment with Foscelantan | Experimental | A prospective, parallel, single-blind clinical study using stratified randomization of the effectiveness, tolerability and safety of the drug "Foscelantan, medicinal plate 4.0×5.0 cm in package No. 1" produced by UNITEHPROM BSU, Republic of Belarusin adult patients with purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome, phase I-II wound process. All patients will receive systemic traditional therapy for the underlying and concomitant diseases. Receives: Drug: Foscelantan |
| Patients with the neuropathic form. Treatment with Povidone-iodine | Active comparator | A prospective, parallel, single-blind clinical study using stratified randomization of the effectiveness, tolerability and safety of the drug Povidone-iodine produced by BelAseptika JSC, in adult patients with purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome, phase I-II wound process. All patients will receive systemic traditional therapy for the underlying and concomitant diseases. Receives: Drug: Povidon-iodine |
| Patients with chronic venous insufficiency. Treatment with Foscelantan | Experimental | A prospective, parallel, single-blind clinical study using stratified randomization of the effectiveness, tolerability and safety of the drug "Foscelantan, medicinal plate 4.0×5.0 cm in package No. 1" produced by UNITEHPROM BSU, Republic of Belarus in adult patients with purulent inflammatory processes of the skin and soft tissues due to chronic venous insufficiency," phase I-II of the wound process. All patients will receive systemic traditional therapy for the underlying and concomitant diseases. Receives: Drug: Foscelantan |
| Patients with chronic venous insufficiency. Treatment with Povidone-iodine | Active comparator | A prospective, parallel, single-blind clinical study using stratified randomization of the effectiveness, tolerability and safety of the drug Povidone-iodine produced by BelAseptika JSC, in adult patients with purulent-inflammatory processes of the skin and soft tissues due to chronic venous insufficiency\", phase I-II of the wound process . All patients will receive systemic traditional therapy for the underlying and concomitant diseases. Receives: Drug: Povidon-iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with trophic ulcers cured
Number of patients cured
Measured: 15 days
Secondary outcomes (1)
percentage reduction in the non-epithelialized area of the wound surface in relation to the initial one
Additionally, the percentage reduction in the non-epithelialized area of the wound surface relative to the original will be calculated, determined by digital non-contact planimetry during dressing changes. This indicator will be assessed using a digital camera and image analysis software
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study startNov 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot InfectionsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Institute for Physical Chemical Problems of the Belarusian State University
- Sponsor type
- University, hospital or other
- Collaborators
- Vitebsk Regional Clinical Hospital, Unitary Enterprise UNITEHPROM BSU, The 10th Minsk City Clinical Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232421
- Sponsor's protocol ID
- OLENKRON-01
- Acronym
- OLENKRON-01
- Status last verified
- Jul 2025
- First submitted
- 7 Jan 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Parallel, Single-blind Clinical Study Using Stratified Randomization of the Effectiveness, Tolerability and Safety of the Medicinal Product "Foscelantan, Medicinal Plate 4.0x5.0 cm in Package No. 1" Produced by UNITEKHPROM BSU, Republic of Belarus, in Comparison With the Medicinal Product Povidone- Iodine Produced by BelAseptika JSC, in Adult Patients With Purulent-inflammatory Processes of the Skin and Soft Tissues Due to the Neuropathic Form of Diabetic Foot Syndrome or Chronic Venous Insufficiency, Phase I-II of the Wound Process
- ClinicalTrials.gov ID
- NCT06232421
- Acronym / sponsor ID
- OLENKRON-01 / OLENKRON-01
- Keywords
- diabetic foot infection, chronic venous insuffiency, lidocaine, cellulose, miramistin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Research Institute for Physical Chemical Problems of the Belarusian State UniversityUniversity, hospital or other
- Collaborators
- Vitebsk Regional Clinical Hospital, Unitary Enterprise UNITEHPROM BSU, The 10th Minsk City Clinical Hospital
- Study start
- Nov 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 30 Jan 2024 (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.
The purpose of this study is to estimate efficiency, tolerance, safety of "Foscelantan, medicinal plate 4.0x5.0 cm in package No. 1" among adult patients who have purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome or chronic venous insufficiency, phase I-II of the wound process.
Detailed description
Diabetes takes the third place in the World in terms of its medical and social significance. Diabetes is often complicated with such urulent-inflammatory processe as diabetic foot syndrome. Urulent-inflammatory processes treatment takes a long time and medications due to microcirculation disorders, metabolic disorders, progressive hypoxia and a number of other factors. A moist wound environment, conducive to the natural process of wound cleansing (autolysis), regeneration of damaged tissue, and reduction of pain, irreversible sorption of excess exudate and toxic components and easy removal of the drug from the surface of the wound without additional trauma or damage are yhe main conditions of successful wound healing.Wound dressings made of fibrous polysaccharides modyfied with drugs meet these requirements. Foscelantan has prolonged antimicrobial, analgesic and reparative action, has the ability to transform on the wound surface into an amorphous gel-like mass, irreversibly bind wound detritus and pathological exudate, and provide optimal conditions for the process of wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with the neuropathic form. Treatment with Foscelantan | Experimental | Drug: FoscelantanA prospective, parallel, single-blind clinical study using stratified randomization of the effectiveness, tolerability and safety of the drug "Foscelantan, medicinal plate 4.0×5.0 cm in package No. 1" produced by UNITEHPROM BSU, Republic of Belarusin adult patients with purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome, phase I-II wound process. All patients will receive systemic traditional therapy for the underlying and concomitant diseases. |
| Patients with the neuropathic form. Treatment with Povidone-iodine | Active comparator | Drug: Povidon-iodineA prospective, parallel, single-blind clinical study using stratified randomization of the effectiveness, tolerability and safety of the drug Povidone-iodine produced by BelAseptika JSC, in adult patients with purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome, phase I-II wound process. All patients will receive systemic traditional therapy for the underlying and concomitant diseases. |
| Patients with chronic venous insufficiency. Treatment with Foscelantan | Experimental | Drug: FoscelantanA prospective, parallel, single-blind clinical study using stratified randomization of the effectiveness, tolerability and safety of the drug "Foscelantan, medicinal plate 4.0×5.0 cm in package No. 1" produced by UNITEHPROM BSU, Republic of Belarus in adult patients with purulent inflammatory processes of the skin and soft tissues due to chronic venous insufficiency," phase I-II of the wound process. All patients will receive systemic traditional therapy for the underlying and concomitant diseases. |
| Patients with chronic venous insufficiency. Treatment with Povidone-iodine | Active comparator | Drug: Povidon-iodineA prospective, parallel, single-blind clinical study using stratified randomization of the effectiveness, tolerability and safety of the drug Povidone-iodine produced by BelAseptika JSC, in adult patients with purulent-inflammatory processes of the skin and soft tissues due to chronic venous insufficiency\", phase I-II of the wound process . All patients will receive systemic traditional therapy for the underlying and concomitant diseases. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The presence of purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome (Main diagnosis: Diabetes mellitus type I or II, clinical metabolic compensation/subcompensation, class I - II according to the Wagner classification) or chronic venous insufficiency (Main diagnosis: Varicose veins dilatation of the veins of the lower extremities, class C6 according to the CEAP classification), phase I-II of the wound process
- The size of the ulcerative defect is from 1 cm² to 20 cm²
- Secondary type of wound healing
- Absence of exposed bones and tendons in the wound
- Absence of severe concomitant diseases in the stage of decompensation, oncological diseases, as well as diseases requiring steroid therapy
Key exclusion criteria (17 listed)
- Individual intolerance or hypersensitivity reactions to the components of the drug Foscelantan
- Neuroischemic form of diabetic foot syndrome
- The presence of serious concomitant pathology (severe form of renal and hepatic failure, systemic connective tissue diseases, severe cardiovascular insufficiency), history and current mental illness
- The need to constantly take drugs from the list of prohibited therapies
- Participation of the patient in another clinical trial within 3 months before the current clinical trial
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 |
|---|---|---|
| Foscelantan"Foscelantan, medicinal plate 4.0x5.0 cm in package No. 1" produced by UNITEHPROM BSU, Republic of Belarus | Drug | Patients with chronic venous insufficiency. Treatment with Foscelantan, Patients with the neuropathic form. Treatment with Foscelantan |
| Povidon-iodinePovidone-iodine solution 100 mg/ml produced by BelAseptika CJSC, Republic of Belarus | Drug | Patients with chronic venous insufficiency. Treatment with Povidone-iodine, Patients with the neuropathic form. Treatment with Povidone-iodine |
Primary outcome
Number of patients with trophic ulcers cured
Time frame: 15 days
Number of patients cured
1 secondary outcome
percentage reduction in the non-epithelialized area of the wound surface in relation to the initial one
Time frame: 15 days
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 25 Jul 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Foscelantan and Povidon-iodine in people with Diabetic Foot Infections and Chronic Venous Insufficiency, run by Research Institute for Physical Chemical Problems of the Belarusian State University at 2 sites in Belarus.
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 17 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 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belarus. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Eugen Grinyuk, Ph.D., Associate professor (+375 17 209-52-54, hryniuk@bsu.by), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with trophic ulcers cured (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2025.