Clinical Trials for Diabetic Foot
There are currently 11 ongoing clinical trials investigating various treatments for diabetic foot conditions, including ulcers, infections, and dry skin. These studies are testing different approaches ranging from antimicrobial solutions and stem cell therapies to growth factor treatments and new medications. Trials are being conducted across several European countries, offering opportunities for patients to access innovative treatments that may help heal wounds that haven’t responded to standard care.
Clinical trial locations
- Czechia
- Denmark
- France
- Germany
- Italy
- Poland
- Spain
- Sweden
Study on Sodium Hypochlorite and Polyhexamethylene Biguanide for Healing Diabetic Foot Ulcers in Patients with Diabetes
This Swedish trial is comparing two antimicrobial treatments for foot ulcers: Hypochlorous Acid and Polyhexamethylene biguanide. Both are applied directly to the wound to prevent infection and promote healing.
Who can participate: Adults 18 years or older with type 1, type 2, or pancreatitis-related diabetes who have a foot ulcer that has been present for at least 10 days and measures at least 9 square millimeters. Participants must provide written consent before joining.
Who cannot participate: Patients with severe infections that have spread beyond the foot, untreated poor blood flow to the legs, recent foot or leg surgery, known allergies to the treatments, current participation in other trials, inability to follow study procedures, or medical conditions that would make participation unsafe.
Study focus: The trial aims to evaluate which antimicrobial treatment is more effective at healing foot ulcers over a 24-week period. Researchers will monitor healing time, changes in ulcer size and depth, and quality of life. The study will also track how many days patients need antibiotics.
Investigational treatments: Hypochlorous Acid and Polyhexamethylene Biguanide are both antimicrobial agents that work by destroying bacteria at the wound site, helping to prevent infection and support the healing process.
Study on the Effects of Autologous Bone Marrow-Derived Mononuclear Cells for Patients with Diabetic Foot Syndrome and Lower Limb Ischemia
This Czech trial is testing a cell therapy approach using a patient’s own bone marrow cells, known as REX-001, to improve blood flow and promote healing in patients with both foot ulcers and poor circulation in the legs.
Who can participate: Adults aged 18 to 90 with type 1 or type 2 diabetes who have foot ulcers or have had a minor amputation below the ankle, plus chronic limb-threatening ischemia confirmed by blood flow tests showing TcPO2 under 40 mm Hg. Signed informed consent is required.
Who cannot participate: Patients with conditions other than foot syndrome or lower limb ischemia, those eligible for PTA (a blood vessel opening procedure), individuals outside the specified age range, or those belonging to vulnerable populations.
Study focus: The trial compares cell therapy with standard treatment to see if the bone marrow-derived cells can improve tissue oxygenation and clinical outcomes. The study will monitor wound healing, pain changes, major amputation rates, and quality of life through questionnaires. The trial is expected to continue until the end of 2027.
Investigational treatment: Autologous Bone Marrow-Derived Mononuclear Cell Therapy uses cells from the patient’s own bone marrow, injected back into the body to enhance blood vessel formation and reduce inflammation, potentially improving healing in areas with poor circulation.
Study on the Safety and Effectiveness of Allogenic Stem Cells for Treating Diabetic Foot Ulcers in Patients with Diabetes
This Polish trial is investigating stem cells taken from fat tissue (alloADSC-DFU-RL or CellReady) applied directly to chronic wounds to promote healing.
Who can participate: Adults over 18 who use study-recommended wound care, have effective birth control (or are postmenopausal or surgically sterile), can understand and agree to participate, and have a neuropathic or neuropathic/ischemic foot ulcer present for at least 6 weeks measuring between 1 and 25 square centimeters. Participants must have good blood flow to the wound area and HbA1c levels of 11% or less.
Who cannot participate: Patients without a foot ulcer, those outside the specified age range, or individuals who are part of a vulnerable population.
Study focus: The six-week study evaluates the safety and effectiveness of stem cell treatment compared to placebo. Researchers will monitor wound size changes, adverse events, pain levels using the Visual Analogue Scale, quality of life using the EQ-5D-5L questionnaire, and the need for additional treatments like antibiotics.
Investigational treatment: Allogeneic Stem Cells (ADSC/ASC) from donor fat tissue are applied to the wound to promote healing and tissue repair through regenerative medicine approaches.
Study on the Use of Plasma Rich in Growth Factors for Treating Foot Ulcers in Diabetic Patients with Peripheral Arterial Disease
This Spanish trial is testing Plasma Rich in Growth Factors (PRGF), a gel made from a patient’s own platelets, for healing foot ulcers in people who have both diabetes and peripheral arterial disease.
Who can participate: Adults at least 18 years old with type 1 or type 2 diabetes who have one or more ulcers below the ankle measuring between 1 and 25 square centimeters, with Peripheral Arterial Disease meeting at least two blood flow criteria (such as absent pulses, specific ankle or finger pressure measurements, or transcutaneous oxygen pressure readings). The ulcer must have an infection level no greater than 1 on the IDSA/IWGDF scale. Participants must be available for observation and have properly completed informed consent.
Who cannot participate: Patients without foot ulcers caused by diabetes and peripheral arterial disease, those outside the specified age range, individuals not in the designated clinical trial group, or those who are part of a vulnerable population.
Study focus: The six-month study evaluates PRGF effectiveness using the RESVECH 2.0 index to measure healing progress at three and six months. Secondary outcomes include changes in ulcer size, frequency of complete closure, amputation risk, and quality of life assessments.
Investigational treatment: Plasma Rich in Growth Factors (PRGF) is prepared from the patient’s blood and applied as a gel to the ulcer. The growth factors stimulate cell growth and healing processes.
Study Comparing Propylene Glycol and Urea Creams for Treating Dry Feet in People with Diabetes
This Swedish trial compares two moisturizing creams for treating very dry skin on the feet: Oviderm (containing propylene glycol) and Canoderm (containing urea), both compared with a non-humectant cream.
Who can participate: Adults 18 years or older with a physician’s diagnosis of Diabetes Mellitus who experience dry skin on both feet with a Xerosis Severity Scale score between 2 and 6, with no more than 1 point difference between feet. Participants must be able to understand and complete forms in Swedish.
Who cannot participate: Patients without very dry skin on their feet, those without diabetes, individuals outside the specified age range, or those belonging to a vulnerable population.
Study focus: The four-week study assesses the severity of dry skin using the Xerosis Severity Scale and measures skin moisture retention, hydration levels, and pH balance. Safety is monitored by documenting side effects and checking vital signs.
Investigational treatments: Two different humectant-containing creams (attracting and holding moisture) are compared with a non-humectant cream to determine which is most effective at reducing dryness and improving skin health.
Study on AUP1602-C for Treating Non-Healing Diabetic Foot Ulcers in Patients
This Italian trial tests AUP1602-C, a cell suspension applied directly to the skin alongside a foam dressing, for ulcers that haven’t improved with standard care.
Who can participate: Adults 18 years or older with Type 1 or Type 2 Diabetes (HbA1c 11.0% or less) who have at least one full-thickness foot ulcer that hasn’t healed by more than 20% after 2 weeks of standard care, has been present for 3 to 12 months, measures between 1.0 and 10.0 square centimeters, and shows no signs of infection. Blood flow tests must show adequate circulation. Women of childbearing potential must use effective birth control and have negative pregnancy tests.
Who cannot participate: Patients with neuroischaemic ulcers (nerve damage plus poor blood supply), those not meeting inclusion criteria, individuals outside the specified age range, or those who are part of a vulnerable population.
Study focus: The 20-week study evaluates how many patients achieve complete wound closure and monitors the safety and tolerability of the treatment through regular assessments of healing progress, ulcer size measurements, infection signs, and pain levels.
Investigational treatment: AUP1602-C is a cell suspension applied directly to the ulcer, promoting healing processes in non-healing wounds through mechanisms still under investigation.
Study on the Effect of Semaglutide on Healing Foot Ulcers in Patients with Type 2 Diabetes
This Danish trial investigates whether semaglutide, a medication typically used for managing blood sugar, can help heal foot ulcers when given as a weekly injection under the skin.
Who can participate: Adults aged 18 to 90 with type 2 diabetes diagnosed for at least 6 months who have a foot ulcer below the ankle measuring at least 5 square millimeters but no more than 3000 square millimeters after cleaning. The largest ulcer will be chosen if multiple ulcers are present.
Who cannot participate: Patients with serious medical conditions affecting study participation, recent heart attack or stroke, severe kidney or liver disease, pregnant or breastfeeding women, current participation in another trial, history of drug or alcohol abuse, allergy to the study medication, or inability to follow study procedures.
Study focus: The 20-week study monitors the proportion of ulcers that completely heal and measures changes in ulcer size from baseline. The treatment involves weekly injections of semaglutide at doses of 0.25 mg, 0.5 mg, or 1 mg, compared with placebo.
Investigational treatment: Semaglutide mimics a natural hormone that helps control blood sugar levels and may improve blood flow and promote healing in ulcerated areas. It belongs to a class of drugs called GLP-1 receptor agonists.
Study on the Safety and Effectiveness of TP-102 for Treating Diabetic Foot Infections in Patients
This Polish trial tests TP-102, a mixture of bacteriophages (viruses that target specific bacteria) applied directly to infected wounds, alongside standard care.
Who can participate: Adults 18 years or older with type 1 or type 2 Diabetes Mellitus (HbA1c 12.0% or less) who have a full-thickness foot ulcer below the ankle present for at least 3 weeks, measuring 20.0 square centimeters or smaller after cleaning, classified as Mild to Moderate infection, infected with at least one of three specific bacteria (Pseudomonas aeruginosa, Staphylococcus aureus, or Acinetobacter baumannii). Participants must be in suitable physical and mental health, with women of childbearing potential using effective contraception and having negative pregnancy tests.
Who cannot participate: Patients with allergic reactions to the treatment, those who received investigational drugs within 30 days, individuals with severe liver or kidney disease, pregnant or breastfeeding women, those with recent alcohol or drug abuse history, patients with conditions making participation unsafe, or those unable to follow study procedures.
Study focus: The approximately one-month study evaluates safety and effectiveness by monitoring wound size reduction, infection improvement, side effects, and overall health changes. Regular follow-up visits track healing progress.
Investigational treatment: TP-102 uses bacteriophages that specifically target and destroy bacteria causing the infection, helping to clear the infection and promote healing through this innovative bacteriophage therapy approach.
Study on the Safety and Effects of Udonitrectag for Treating Diabetic Foot Ulcers in Patients
This Italian trial tests Udonitrectag (MT8), a solution that mimics neurotrophins (proteins supporting nerve cell growth) applied directly to ulcers alongside standard care.
Who can participate: Adults 18 years or older with type 1 or type 2 diabetes (HbA1c 10% or less) who have a grade I or II foot wound (according to TEXAS classification and PEDIS infection scale grade 1) with adequate tissue oxygen or blood flow measurements. The ulcer must not have healed with standard care over two weeks (less than 20% reduction) and must measure between 2 and 15 square centimeters. Women of childbearing potential must use effective contraception and have negative pregnancy tests.
Who cannot participate: Patients with active infection in the ulcer area, poor leg circulation, recent foot or leg surgery, severe kidney or liver disease, pregnant or breastfeeding women, current participation in another trial, history of allergic reactions to similar treatments, immune system conditions, or inability to follow study procedures.
Study focus: The six-week study assesses safety, tolerability, and pharmacokinetics (how the body processes the treatment) as primary endpoints. The secondary endpoint measures the percentage of patients achieving at least 50% reduction in ulcer area. Monitoring includes skin irritation observations, laboratory tests, and vital parameters.
Investigational treatment: Udonitrectag (MT8) is a neurotrophin mimetic applied topically to enhance cellular repair and regeneration processes, potentially improving healing when used with standard care.
Treatment Study of Diabetic Foot Ulcers Using Autologous Stromal Vascular Fraction Cells for Patients with Non-healing Wounds
This French trial tests stromal vascular fraction (SVF) cells obtained from a patient’s own fat tissue, injected directly into the wound area.
Who can participate: Adults at least 18 years old with type 1 or type 2 diabetes (HbA1c less than 10% within the last month) who have a foot ulcer measuring between 1 and 15 square centimeters that hasn’t improved with standard treatment for at least 2 months, shows no infection signs, and has adequate blood flow. Participants must have confirmed nerve damage (neuropathy) in the foot, a BMI of at least 18.5 kg/m², be in good overall health, and be willing to wear prescribed dressings and pressure relief systems. Women of childbearing potential must have negative pregnancy tests and use reliable contraception.
Who cannot participate: Individuals under 18 or over 65 years, pregnant or breastfeeding women, those with active ulcer infection, bone infection (osteomyelitis), uncontrolled diabetes, severe peripheral vascular disease, active or recent cancer (within 5 years), severe kidney disease requiring dialysis, blood clotting disorders, current participation in other trials, known allergies to study materials, inability to follow procedures, major amputation in the affected limb, gangrene, or severe heart or lung disease.
Study focus: The 20-week study (running from January 2024 to March 2028) evaluates whether local SVF injection can promote complete ulcer healing. Maximum dose is 15 milliliters per treatment session. Regular monitoring tracks healing progress.
Investigational treatment: Stromal Vascular Fraction (SVF) contains various regenerative cells including stem cells from the patient’s fat tissue, working to promote tissue healing and regeneration through natural healing processes. This represents an advanced therapy medicinal product in regenerative medicine.
Study on AUP1602-C for Treating Non-Healing Diabetic Foot Ulcers in Patients
This multi-country trial (Italy, Poland, Germany) tests AUP1602-C, a topical cell suspension, for non-healing neuro-ischemic ulcers caused by both nerve damage and poor blood flow.
Who can participate: Adults 18 years or older in good physical and mental health with type 1 or type 2 diabetes (HbA1c 11.0% or lower) who have at least one ulcer that hasn’t healed by more than 20% during a 2-week standard care period, has been present for 4 weeks to 12 months, is located on the foot at or below the ankle, measures between 1.0 and 10.0 square centimeters, doesn’t involve bone or joints, shows no active infection, and is suitable for foam dressings. Blood flow tests must show adequate circulation. Participants must agree to wear special pressure-reducing footwear. Women of childbearing potential must use effective birth control and have negative pregnancy tests.
Who cannot participate: Patients with serious health conditions interfering with the study, pregnant or breastfeeding women, those with allergies to study medications, recent participation in other trials (within 30 days), poorly controlled diabetes, active infections requiring antibiotics, major surgery within 3 months, history of substance or alcohol abuse, inability to follow procedures, or unstable kidney or liver function.
Study focus: The trial evaluates safety, tolerability, and effectiveness of AUP1602-C in achieving complete wound closure within 20 weeks. A two-week run-in period assesses ulcer response to standard care before randomization. Follow-up continues at 6 and 12 months to monitor for recurrence. Dosage is 2.5 x 10^8 CFU per square centimeter of ulcer size.
Investigational treatment: AUP1602-C is a wound healing agent applied topically to enhance the body’s natural healing processes through mechanisms still under investigation, classified as a topical wound care agent.
Summary
The 11 ongoing clinical trials for diabetic foot conditions demonstrate a diverse approach to addressing this challenging complication. The trials are concentrated primarily in European countries, with Poland and Italy hosting the most studies (3 each), followed by Sweden (2), and single trials in Czechia, Denmark, France, Spain, and Germany.
Several trials focus on innovative regenerative medicine approaches, including stem cell therapies and cell-based treatments such as bone marrow-derived cells, adipose tissue-derived stem cells, and stromal vascular fraction. These represent cutting-edge approaches that harness the body’s natural healing capabilities.
AUP1602-C is being tested in three separate trials across multiple countries, indicating significant research interest in this particular cell suspension treatment for non-healing ulcers. Other notable investigations include antimicrobial solutions, bacteriophage therapy for infections, growth factor treatments, and medications like semaglutide that may have healing properties beyond their primary indications.
Most trials focus on ulcers that haven’t responded to standard care, typically requiring wounds to be present for several weeks to months. Common eligibility criteria across studies include specific ulcer size ranges (generally 1-25 square centimeters), adequate blood flow measurements, and controlled diabetes with HbA1c levels typically below 10-12%. Treatment durations vary from 4 weeks to 24 weeks, with many trials including extended follow-up periods to monitor long-term outcomes and recurrence rates.
The variety of approaches being studied reflects the complex nature of diabetic foot conditions and the need for multiple treatment options to address different aspects of the disease, from infection control to tissue regeneration and improved circulation.
