An interventional study of Curi01 and Standard of Care in Diabetic Foot Disease, Foot Ulcer Due to Type 1 Diabetes Mellitus and Foot Ulcer Due to Type 2 Diabetes Mellitus, sponsored by Cutempa Medical AG. Recruiting at 13 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Cutempa Medical AG · Not applicable, Interventional, and Treatment
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Among 37 studies in Diabetic Foot with a site in Germany — 4 open to participants now, 4 under way, none of them phase 3. Diabetic Foot · Germany.
Among the 37 studies in Diabetic Foot with a site in Germany, this one is the 6th largest by planned enrollment of the 29 interventional ones that give a count, is one of 2 that started in 2026, is one of 9 with no phase, and was the 37th registered.
1,078 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
Browse Diabetic Foot studies →4 of the 37 studies in Diabetic Foot with a site in Germany are open now. Recruiting first, the newest first:
Heinrich-Heine University, Duesseldorf · Sites in Germany
Ages 18+
VULM s.r.o. · Sites in Germany, Poland
Ages 18–85
Barbara Wolff-Winiski · Sites in Germany
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 137 Diabetic Foot studies recruiting now, 96 (70%) set no upper age limit and 12 (9%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
37 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 10 · Phase 3 11 · Phase 4 1
First in 2002; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 280 is above the median of 60 across 848 interventional studies indexed under Diabetic Foot.
Median enrollment 136 across the 29 interventional studies, 89 across the 8 observational. Of the 29 that completed or were terminated, 11 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
25 of 37 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Cutempa Medical AG as lead sponsor.
Cutempa Medical AG has 1 study filed under Diabetic Foot — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 37 studies in Diabetic Foot with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to learn if Curi01, a powder made of silica (silicon dioxide) particles, helps chronic, oozing diabetic foot ulcers heal when it is added to standard wound care. Curi01 is sprinkled directly onto the wound, where it soaks up wound fluid and forms a gel that is washed off at the next dressing change.
The main questions it aims to answer are:
Do more wounds heal completely within 12 weeks when Curi01 is added to standard wound care, compared with standard wound care alone? A wound counts as healed when it is fully closed and still closed 14 days later.
Is Curi01 safe and well tolerated?
Researchers will compare Curi01 plus standard wound care to standard wound care alone. Standard wound care includes removing dead tissue, cleaning the wound, non-medicated dressings and pressure relief for the foot if applicable.
Participants will:
Be adults with type 1 or type 2 diabetes who have an oozing foot ulcer (2 to 10 cm²) that has been present for at least 6 weeks and has not improved enough with standard wound care First receive standard wound care for 2 weeks to check whether the wound improves on its own Then be assigned by chance to one of the two groups; 2 out of 3 participants will receive Curi01 Visit the study site up to 18 times over about 14 weeks; in the Curi01 group, the powder is applied at each visit until the wound is dry Have their wound photographed and measured with a wound imaging app at each visit Answer questionnaires about their quality of life and how they feel their condition has changed Be asked about any side effects or health problems
About 280 participants will take part at around 20 study sites in Germany. Participants and doctors will know which treatment is being given.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of Screening Visit (Visit 1) are acceptable (may also be the status after revascularization):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Curi01 silica microparticle powder applied topically to the target wound (layer of approx. 3-5 mm, covering the entire wound surface) at each study visit, followed by a sterile dressing, in addition to standard of care, for up to 12 weeks. Application may be stopped after Day 8 once the wound is dry and restarted if exudation resumes.
Device: Curi01 · Other: Standard of Care
Standard of care alone for up to 12 weeks: debridement as needed, wound cleansing with sterile saline or approved antiseptic, non-active wound dressings, offloading, and compression therapy if indicated.
Other: Standard of Care
Sterile, powder-based wound exudate adsorbing agent composed of two types of silicon dioxide particles. Applied topically to the target wound evenly and generously (layer of approx. 3-5 mm) until the wound surface is completely covered, then covered with a sterile dressing. Applied at each study visit for up to 12 weeks; may be stopped once the wound is dry and restarted if exudation resumes. Class IIb medical device, not CE-marked (investigational).
Standard wound care as defined in the protocol: debridement (sharp/surgical or mechanical) as needed, wound cleansing with sterile saline or an approved antiseptic (polyhexanide, octenidine or chlorhexidine), non-active wound dressings without antimicrobial, pharmacologic or biological agents, offloading if applicable, and compression therapy if indicated.
Proportion of Participants With Healed Target Wound at Day 84
Healing is defined as complete wound closure (confirmed by the investigator for the first time) without drainage, with closure confirmed again 14 days later. Wound closure may only be confirmed by the investigator after the wound imaging software (Pixacare WoundTrack-II) has registered a wound area below 1 cm². Healing confirmed at an earlier visit is carried forward to Day 84. The difference in proportions between Curi01 + standard of care and standard of care alone is assessed for superiority.
Time frame: Day 84
Percentage Reduction in Wound Area From Baseline
Percentage reduction in target wound area (cm²) from Baseline (Visit 2, Day 1), measured with the wound imaging software Pixacare WoundTrack-II from a calibrated photograph. Compared between Curi01 + standard of care and standard of care alone.
Time frame: Baseline (Day 1), Day 28, Day 35, Day 42 and Day 84
Time to Complete Wound Granulation
Time from Baseline (Day 1) to complete granulation of the target wound, with granulation tissue (%) measured by the Pixacare WoundTrack-II tissue analysis module.
Time frame: Baseline (Day 1) up to Day 84
Time to Complete Wound Closure
Time from Baseline (Day 1) to complete closure of the target wound, confirmed by the investigator after the wound imaging software (Pixacare WoundTrack-II) has registered a wound area below 1 cm².
Time frame: Baseline (Day 1) up to Day 84
Time to 25% Reduction in Wound Area
Time from Baseline (Day 1) until the target wound area (cm²), measured with Pixacare WoundTrack-II, has decreased by at least 25% compared with Baseline.
Time frame: Baseline (Day 1) up to Day 84
Proportion of Participants With Healed Target Wound at Day 28 and Day 63
Healing is defined as complete wound closure (confirmed by the investigator for the first time) without drainage, with closure confirmed again 14 days later. Healing confirmed at an earlier visit is carried forward to later visits.
Time frame: Day 28 and Day 63
Change From Baseline in Diabetic Foot Ulcer Scale - Short Form (DFS-SF) Score
Disease-specific health-related quality of life assessed with the validated 29-item DFS-SF questionnaire. Change from Baseline (Day 1) is compared between treatment groups.
Time frame: Baseline (Day 1), Day 42 and Day 84
Incidence of Adverse Events (AEs) and Adverse Device Effects (ADEs)
Number and percentage of participants with AEs and ADEs, including serious events, recorded from Baseline (Day 1) until the end of study visit.
Time frame: Baseline (Day 1) up to Day 84 (or Day 91/98 for participants with an additional follow-up visit)
Patient's Global Impression of Improvement (CGI-I)
Patient-rated global improvement on a scale from 1 (very much better) to 7 (very much worse).
Time frame: Day 42 and Day 84
Change From Baseline in PEDIS Classification
Diabetic foot ulcer severity assessed by the investigator using the PEDIS classification (Perfusion, Extent, Depth, Infection, Sensation).
Time frame: Baseline (Day 1), Day 42 and Day 84
Number of Participants Requiring Antibiotic Treatment of the Target Wound
Number of participants in each group who receive local or systemic antibiotic treatment for the target wound during the study.
Time frame: Baseline (Day 1) up to Day 84
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Feb 2028, 18 months after the start.
Of 103 industry-sponsored interventional studies with no phase under Diabetic Foot, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 18 months is below that.
Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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