Diabetic Foot UlcerPhase 2NCT06111183
Evaluation of AUP12602-C as New Topical Treatment for DFUs (DIAMEND STUDY)
A Phase 2 study testing AUP1602-C in people with Diabetic Foot Ulcer, run by Aurealis Oy at 10 sites in 3 countries.
Trial summary
This is a phase 2 study performed in diabetic foot ulcer (DFU) patients with chronic non-healing, neuro-ischemic wounds to investigate the safety, tolerability and efficacy of AUP1602-C. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- AUP1602-C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 21 Jul 2023to 28 Nov 2025
- Phase
- Phase 2
- 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
- Male or female patients aged 18 and above
- Patients with DM of type 1 or 2 having a glycosylated haemoglobin (HbA1c) of ≤ 11.0% OR 97.0 mmol/mol OR 14.9 mmol/l at randomization undergoing therapy for glycaemic control using available diabetes drugs including insulin
- Patients with at least one DFU that fulfils all the following criteria:
- Non-healing target ulcer defined as ≤ 20.0% reduction in area in response to SoC during the 2-weeks run-in period,
- Duration: ≥ 4 weeks and ≤ 12 months at screening visit 1,
- Located either in the plantar or on the dorsum of foot, or at or below the ankle,
Show all 19Show fewer
- Ulcer is accessible for administration of IMP and can be completely covered by the primary and secondary dressings,
- Full-thickness, not involving bone or joints (i.e., University of Texas classification Grade 1A, 1C, 2A, 2C)(5),
- No clinical signs of active wound infection defined by IDSA/IWGDF criteria(6) or clinical evidence osteomyelitis at randomization (V1),
- Area of the target ulcer between 1.0-10.0 cm2 after debridement at randomization (V1)
- Ulcer and periwound tissue suitable for application of film dressings (i.e., no contraindications and sufficient periwound space to hold the dressing).
- Patients with more than one ulcer will be included if ulcers are separated by a minimum of 2.0 cm healthy tissue. The largest ulcer fulfilling the inclusion criteria will be selected for the investigational treatment.
- Patients with either an ankle brachial index (ABI) ≥ 0.7 OR a toe-brachial index (TBI) ≥ 0.5, AND a toe systolic pressure of at least 50.0 mmHg (or ankle systolic pressure of at least 70.0 mmHg if toe-pressure is not measured) on the foot with the target ulcer.
- Revascularized patients with an ulcer fulfilling the inclusion criteria can be included 3.0 months after the procedure.
- Patients with an assessment of the baseline level of neuropathy in the lower limb where the target ulcer is located.
- Patients must be willing to wear off-loading footwear, while ambulating, for the period requested by the Investigator.
- A woman of childbearing potential (WOCBP) must have a negative serum pregnancy test at the time of screening after sign the informed consent and a negative pregnancy dip-stick test at baseline (before starting treatment).
- Females of childbearing potential must agree to use a highly effective contraceptive measure (methods that can achieve a failure rate of less than 1% per year when used consistently and correctly) , throughout the study. / Male patients who are biologically capable of having children must agree to apply at least two methods of contraception including male barrier protection throughout the study.
- Patients who understand and are willing to comply with study procedures and give written informed consent prior to enrolment in the study or initiation of study procedures.
Who cannot join
- Participating in another clinical study or treatment with another investigational product and/or medical device in the 30 days prior to inclusion in the study or within the 5 half-lives of the investigational product, whichever is longer.
- Current or previous (within 30 days prior to start of run-in period) treatment of target ulcer with a treatment that could interfere with wound healing/IMP such as biological agents, growth factors, skin equivalents/substitutes (e.g., Regranex®, Apligraf®, or Dermagraft®), keratinocytes, platelet-rich-plasma, collagen products, blood products, placental products, oxygen therapy, topical steroids.
- Current or previous (within 1 week prior to first IMP (AUP1602-C or placebo) dosing) treatment with active wound care agents (e.g., local/topical antibiotics OR antibacterials such as silver, iodine, chlorhexidine) OR systemic antibiotics for any indication.
- Current or previous (within 2 weeks prior to first IMP (AUP1602-C or placebo) dosing) use of corticosteroids and immunosuppressants. Treatment with immunosuppressive agents with known therapeutic effects longer than 2 weeks may be considered as exclusion and should be consulted with Medical Monitor/Sponsor.
- Known hypersensitivity to any of the components of AUP1602-C or placebo
- Ulcer of University of Texas Grade ≥ 3, with deep abscess, sinus track, necrosis or gangrene that cannot be removed by debridement.
Show all 33Show fewer
- Target ulcers with excessive exudation requiring more than one dressing change within 24-hrs.
- Target ulcers with clinically significant periwound skin maceration.
- Target ulcer with known or suspected active infection, which requires antimicrobials. Any antibiotic therapy must be completed or discontinued within 1 week prior to first IMP (AUP1602-C or placebo) dosing.
- Target ulcers requiring urgent vascular surgical interventions.
- Target ulcer other than non-healing DFU fulfilling inclusion criteria (e.g., including, but not limited to, pressure ulcers, burn wounds).
- Serum creatinine level of > 3.0 times the upper limit of normal (ULN).
- Prior radiation therapy (within 6 weeks prior to first IMP (AUP1602-C or placebo) dosing) of any part of the foot/leg bearing the target ulcer under study or total body irradiation.
- Sickle-cell diseases, Reynaud's, or other peripheral vascular disease including venous leg ulcers or any vasculitic ulcer irrespective of the cause will be excluded.
- Active or unstable Charcot deformity of the study foot (i.e., foot is erythematous, warm, oedematous, and is actively remodelling).
- Patients with other reasons for wound healing disturbances: e.g., bleeding disorders, vitamin K deficiency, hypocalcaemia, major immune deficiencies.
- Active malignant disease of any kind except for basal cell carcinoma (of the skin) not co-located with the target ulcer. A patient, who has had a malignant disease in the past, completed treatment and is currently disease-free and not on active treatment for at least 3 months, may be considered for study entry. Cancer therapies with known therapeutic effects longer than 3 months may be considered as exclusion and should be consulted with Medical Monitor/Sponsor.
- Haemoglobin of less than 8.5 g/dL
- Liver transaminase \& total bilirubin levels greater than 3 times ULN.
- Patients receiving haemodialysis or continuous ambulatory peritoneal dialysis (CAPD) therapy.
- Positive for hepatitis B or C virus (HBV, HCV), or human immunodeficiency virus (HIV) (serology test results up to 3 months prior signing ICF accepted).
- Patients with confirmed active infection with SARS-CoV-2 and related disease (COVID-19) at Baseline (V1) prior to first administration of trial medication.
- Planned major surgery during the run-in, treatment and post-treatment efficacy and safety follow-up period of the study.
- Known abuse of alcohol, drugs, or medical products. Tobacco use will be allowed.
- Previous treatment with AUP1602-C.
- Any diagnosed unstable psychological or physical condition including major organ failure that could interfere with compliance.
- Myocardial infarction diagnosed within 1 month prior to start of run-in period.
- White Blood Cells (WBC) < 3.0 X 109 cells/L；> 12.0 X 109 cells/L
- Albumin < 2.5 g/dL (or total protein < 4.0 g/dl).
- The patient has any other factor/reason which may, in the opinion of the Investigator, compromise participation and/or follow-up in the study.
- Pregnant or lactating woman at the time of signing the informed consent and prior to first IMP (AUP1602-C or placebo) dosing.
- Close affiliation with the Investigator (e.g., a close relative, financially dependent on the investigational site) or patient who is an employee of the Sponsor's company.
- Patients who are institutionalized because of legal or regulatory order.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Italy4 sites
Ospedale San Donato
Arezzo
Azienda Ospedaliero-Universitaria Careggi
Florence
AOU Pisana - Ospedale S. Chiara
Pisa
Ospedale S. Jacopo Pistoia, Diabetologia e Diabetic foot unit Aziendale
Pistoia
Poland4 sites
Mikomed
Lodz
Med-Polonia SP. Z O.O.
Poznan
PODOS Klinika Leczenia Ran Podema sp. z o.o.
Warsaw
Lecran Centrum Opieki Nad Ranami
Wroclaw
Germany2 sites
Institut für Diabetesforschung Muenster GmbH
Münster
Hauärztliche und Diabetologische Praxis
Pirna
About this study
Official title: Phase-2, Multi-centre, Prospective, Randomized, Standard-of-care Plus Placebo-controlled, Patient and Central Evaluator Blinded, Parallel Arm, Clinical Study to Evaluate Safety, Tolerability and Efficacy of the AUP1602-C as Treatment for Non-healing Neuro-ischemic DFU
This is a phase 2 study performed in diabetic foot ulcer (DFU) patients with chronic non-healing, neuro-ischemic wounds to investigate the safety, tolerability and efficacy of AUP1602-C.
Read the detailed description
This is a phase 2 multi-centre, parallel arm, patient and central evaluator-blinded, randomized, SoC plus placebo-controlled study of the RP2D of AUP1602-C performed in DFU patients with non-healing wounds. The RP2D of AUP1602-C derived from phase 1 study is 2.5 x 10E8 CFU/cm2 ulcer area and is used in this study.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- AUP1602-C, Placebo
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUP1602-CBiological
AUP1602-C is topically applied on chronic wounds and covered by wound dressing.
PlaceboOther
Placebo is topically applied on chronic wounds and covered by wound dressing.
| Study group | Role | What they receive |
|---|---|---|
| AUP1602-C | Experimental | AUP1602-C is administered topically during the treatment period. Receives: Biological: AUP1602-C |
| Placebo | Placebo comparator | Placebo is administered topically during the treatment period. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of local and systematic adverse events (AEs)
Incidence of local and systematic adverse events (AEs) for repeatedly administered AUP1602-C and of the placebo control arm.
Measured: 6 weeks
Incidence of Wound Closure
Proportion of patients with a target ulcer achieving complete wound closure
Measured: 20 weeks
Secondary outcomes (12)
To evaluate the effect size of the efficacy parameters for AUP1602-C and placebo control arm in DFU patients
- Percentage of wound area reduction
- Percentage of wound volume and depth reduction
Measured: 20 weeks
To evaluate the effect size of the efficacy parameters for AUP1602-C and placebo control arm in DFU patients
- Time to complete wound closure
- Time to >50% wound area reduction
- Time to >75% wound area reduction
Measured: 20 weeks
To evaluate the effect size of the efficacy parameters for AUP1602-C and placebo control arm in DFU patients
- Proportion of patients with complete wound closure
- Proportion of patients with a >50% wound area reduction
- Proportion of patients with a >75% wound area reduction
- Proportion of patients with a target ulcer recurrence
Measured: 20 weeks
To evaluate the effect of the RP2D and selected treatment schedules on the percentage of wound area reduction in DFU patients
- Percentage of wound area reduction
Measured: 20 weeks
To evaluate the effect of the RP2D and selected treatment schedules on the percentage of wound area reduction in DFU patients
- Time to complete wound closure
- Time to >50% wound area reduction
- Time to >75% wound area reduction
Measured: 20 weeks
To evaluate the effect of the RP2D and selected treatment schedules on the percentage of wound area reduction in DFU patients
- Proportion of patients with complete wound closure
- Proportion of patients with a >50% wound area reduction
- Proportion of patients with a >75% wound area reduction
Measured: 20 weeks
To evaluate the effect of the RP2D and selected treatment schedules long-term healing in DFU patients
- Proportion of patients with complete wound closure
Measured: 20 weeks
To evaluate the effect of the RP2D and selected treatment schedules ulcer recurrence in DFU patients
- Proportion of patients with a target ulcer recurrence
Measured: 20 weeks
Changes in Quality of Life according to EQ-5D-5L
Change from baseline in health-related quality is assessed according to EuroQoL-5 Dimensions (EQ-5D-5L) patient quesionnaire. Five single-item dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. Result of the questionnaire is scored from 0 (worst health imaginable) to 100 (best health imaginable).
Measured: 20 weeks
Changes in Quality of Life according to DLQI
Change from baseline in health-related quality is assessed according to Dermatology Life Quality Index (DLQI). It consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score will be calculated as the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Measured: 20 weeks
Changes in pain assessment according to VAS
Change from baseline in patient's pain intensity according to a numerical Visual Analog Scale (VAS) ranging from 0 = no pain to 10= worst imaginable pain.
Measured: 20 weeks
Incidence of target ulcer related hospital visits
- Number of target ulcer related hospital visits
- Number of patient-days of hospitalization due to complications related to target ulcer
- Number of patient-days of target ulcer related antibiotic therapy
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start21 Jul 2023
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurealis Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111183
- Sponsor's protocol ID
- AT-W-CLI-2022-04
- Status last verified
- Feb 2026
- First submitted
- 9 Oct 2023
- Last updated
- 12 Feb 2026
- 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase-2, Multi-centre, Prospective, Randomized, Standard-of-care Plus Placebo-controlled, Patient and Central Evaluator Blinded, Parallel Arm, Clinical Study to Evaluate Safety, Tolerability and Efficacy of the AUP1602-C as Treatment for Non-healing Neuro-ischemic DFU
- ClinicalTrials.gov ID
- NCT06111183
- Acronym / sponsor ID
- AT-W-CLI-2022-04
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Aurealis OyIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 1 Nov 2023 (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 is a phase 2 study performed in diabetic foot ulcer (DFU) patients with chronic non-healing, neuro-ischemic wounds to investigate the safety, tolerability and efficacy of AUP1602-C.
Detailed description
This is a phase 2 multi-centre, parallel arm, patient and central evaluator-blinded, randomized, SoC plus placebo-controlled study of the RP2D of AUP1602-C performed in DFU patients with non-healing wounds. The RP2D of AUP1602-C derived from phase 1 study is 2.5 x 10E8 CFU/cm2 ulcer area and is used in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AUP1602-C | Experimental | Biological: AUP1602-CAUP1602-C is administered topically during the treatment period. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo is administered topically during the treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female patients aged 18 and above
- Patients with DM of type 1 or 2 having a glycosylated haemoglobin (HbA1c) of ≤ 11.0% OR 97.0 mmol/mol OR 14.9 mmol/l at randomization undergoing therapy for glycaemic control using available diabetes drugs including insulin
- Patients with at least one DFU that fulfils all the following criteria:
- Patients with more than one ulcer will be included if ulcers are separated by a minimum of 2.0 cm healthy tissue. The largest ulcer fulfilling the inclusion criteria will be selected for the investigational treatment.
- Patients with either an ankle brachial index (ABI) ≥ 0.7 OR a toe-brachial index (TBI) ≥ 0.5, AND a toe systolic pressure of at least 50.0 mmHg (or ankle systolic pressure of at least 70.0 mmHg if toe-pressure is not measured) on the foot with the target ulcer.
Key exclusion criteria (33 listed)
- Participating in another clinical study or treatment with another investigational product and/or medical device in the 30 days prior to inclusion in the study or within the 5 half-lives of the investigational product, whichever is longer.
- Current or previous (within 30 days prior to start of run-in period) treatment of target ulcer with a treatment that could interfere with wound healing/IMP such as biological agents, growth factors, skin equivalents/substitutes (e.g., Regranex®, Apligraf®, or Dermagraft®), keratinocytes, platelet-rich-plasma, collagen products, blood products, placental products, oxygen therapy, topical steroids.
- Current or previous (within 1 week prior to first IMP (AUP1602-C or placebo) dosing) treatment with active wound care agents (e.g., local/topical antibiotics OR antibacterials such as silver, iodine, chlorhexidine) OR systemic antibiotics for any indication.
- Current or previous (within 2 weeks prior to first IMP (AUP1602-C or placebo) dosing) use of corticosteroids and immunosuppressants. Treatment with immunosuppressive agents with known therapeutic effects longer than 2 weeks may be considered as exclusion and should be consulted with Medical Monitor/Sponsor.
- Known hypersensitivity to any of the components of AUP1602-C or placebo
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 |
|---|---|---|
| AUP1602-CAUP1602-C is topically applied on chronic wounds and covered by wound dressing. | Biological | AUP1602-C |
| PlaceboPlacebo is topically applied on chronic wounds and covered by wound dressing. | Other | Placebo |
Primary outcome
Incidence of local and systematic adverse events (AEs)
Time frame: 6 weeks
Incidence of local and systematic adverse events (AEs) for repeatedly administered AUP1602-C and of the placebo control arm.
Incidence of Wound Closure
Time frame: 20 weeks
Proportion of patients with a target ulcer achieving complete wound closure
12 secondary outcomes
To evaluate the effect size of the efficacy parameters for AUP1602-C and placebo control arm in DFU patients
Time frame: 20 weeks
To evaluate the effect size of the efficacy parameters for AUP1602-C and placebo control arm in DFU patients
Time frame: 20 weeks
To evaluate the effect size of the efficacy parameters for AUP1602-C and placebo control arm in DFU patients
Time frame: 20 weeks
To evaluate the effect of the RP2D and selected treatment schedules on the percentage of wound area reduction in DFU patients
Time frame: 20 weeks
To evaluate the effect of the RP2D and selected treatment schedules on the percentage of wound area reduction in DFU patients
Time frame: 20 weeks
To evaluate the effect of the RP2D and selected treatment schedules on the percentage of wound area reduction in DFU patients
Time frame: 20 weeks
To evaluate the effect of the RP2D and selected treatment schedules long-term healing in DFU patients
Time frame: 20 weeks
To evaluate the effect of the RP2D and selected treatment schedules ulcer recurrence in DFU patients
Time frame: 20 weeks
Changes in Quality of Life according to EQ-5D-5L
Time frame: 20 weeks
Changes in Quality of Life according to DLQI
Time frame: 20 weeks
Changes in pain assessment according to VAS
Time frame: 20 weeks
Incidence of target ulcer related hospital visits
Time frame: 20 weeks
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 12 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AUP1602-C in people with Diabetic Foot Ulcer, run by Aurealis Oy at 10 sites in 3 countries.
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 19 inclusion and 33 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 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy, Poland, Germany. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of local and systematic adverse events (AEs) (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 12 Feb 2026.