Authorised Therapeutic exploratory (Phase II) Diabetic Foot Ulcer

Phase 2A–Evaluation of AUP1602-C with foam dressing as a new treatment for diabetic foot ulcers

EU CTIS ID: 2024-519317-66-00

What this study is testing

Efficacy: To assess the proportion of patients achieving complete wound closure at 20 weeks after starting treatment with AUP1602-C plus SoC in patients with non-healing, neuroischaemic o assess the proportion of patients achieving complete wound closure at 20 eeks after starting treatment with AUP1602-C plus SoC in patients with non-healing, neuroischaemic DFU, fulfilling inclusion criteria DFU, fulfilling inclusion criteria Safety and Tolerability: To assess local and systemic safety and tolerability of the dose 2.5 x 108 CFU/cm2 ulcer size of AUP1602-C plus SoC up to 20 weeks from the first administration of AUP1602-C in patients with non-healing, neuroischaemic DFU, fulfilling inclusion criteria

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Male or female patients aged 18 years and above, depending on the Investigator’s assessment of physical and psychological wellbeing of the patient to comply with study procedures and FU.
  • WOCBP 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)2 , 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.
  • Patients with DM of type 1 or 2 having an HbA1c of ≤ 11.0% OR 97.0 mmol/mol OR 14.9 mmol/L at the screening visit S-V1(results up to 3 months prior to signing ICF accepted) undergoing therapy for glycaemic control using available diabetes drugs including insulin
  • Patients with at least one DFU that fulfils all of 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: ≥ 3 months and ≤ 12 months at screening visit 1 (S-V1), • Located either in the plantar or on the dorsum of foot, or at or below the ankle, • Ulcer is accessible for administration of AUP1602-C 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)(2) , • No clinical signs of active wound infection defined by IDSA/IWGDF criteria(3) or clinical evidence of osteomyelitis at screening visit 1 (S-V1), • Area of the target ulcer between 1.0-10.0 cm2 after debridement at screening visit 1 (S-V1) • Ulcer and peri-wound tissue suitable for application of foam dressings (i.e., no contraindications and sufficient peri-wound space to hold the dressing). • Ulcer area can be reliably measured by the planimetry method for determining treatment volume and assessing progression towards healing
  • 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.

You likely can't join if

  • Current or previous (within 2 weeks prior to start of run-in period) treatment with another investigational drug and/or medical device or participation in another clinical study.
  • Haemoglobin of less than 8.5 g/dL.
  • Liver transaminase and total bilirubin levels > 3 x ULN
  • 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 or other cell therapies, collagen products, blood products, placental products, oxygen therapy, topical steroids or cold plasma.
  • Patients receiving haemodialysis or CAPD therapy.
  • Positive for HBV, HCV, or HIV (serology test results up to 3 months prior signing ICF accepted).
See the full eligibility criteria
Who can join
  • Male or female patients aged 18 years and above, depending on the Investigator’s assessment of physical and psychological wellbeing of the patient to comply with study procedures and FU.
  • WOCBP 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)2 , 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.
  • Patients with DM of type 1 or 2 having an HbA1c of ≤ 11.0% OR 97.0 mmol/mol OR 14.9 mmol/L at the screening visit S-V1(results up to 3 months prior to signing ICF accepted) undergoing therapy for glycaemic control using available diabetes drugs including insulin
  • Patients with at least one DFU that fulfils all of 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: ≥ 3 months and ≤ 12 months at screening visit 1 (S-V1), • Located either in the plantar or on the dorsum of foot, or at or below the ankle, • Ulcer is accessible for administration of AUP1602-C 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)(2) , • No clinical signs of active wound infection defined by IDSA/IWGDF criteria(3) or clinical evidence of osteomyelitis at screening visit 1 (S-V1), • Area of the target ulcer between 1.0-10.0 cm2 after debridement at screening visit 1 (S-V1) • Ulcer and peri-wound tissue suitable for application of foam dressings (i.e., no contraindications and sufficient peri-wound space to hold the dressing). • Ulcer area can be reliably measured by the planimetry method for determining treatment volume and assessing progression towards healing
  • 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 ABI ≥ 0.7 OR a 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 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 WOCBP must have a negative serum pregnancy test at the time of screening after signing the ICF and a negative pregnancy dip-stick test at baseline (before starting treatment)
What rules you out
  • Current or previous (within 2 weeks prior to start of run-in period) treatment with another investigational drug and/or medical device or participation in another clinical study.
  • Haemoglobin of less than 8.5 g/dL.
  • Liver transaminase and total bilirubin levels > 3 x ULN
  • 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 or other cell therapies, collagen products, blood products, placental products, oxygen therapy, topical steroids or cold plasma.
  • Patients receiving haemodialysis or CAPD therapy.
  • Positive for HBV, HCV, or HIV (serology test results up to 3 months prior signing ICF accepted).
  • Patients with confirmed active infection with SARS-CoV-2 and related disease (COVID19) at Baseline (V1) prior to first administration of trial medication
  • Planned major surgery during the run-in, treatment and efficacy and FU 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.
  • Target ulcers requiring urgent vascular surgical interventions.
  • Myocardial infarction diagnosed within 1 month prior to start of run-in period.
  • 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).
  • Current or previous (within 1 week prior to first AUP1602-C 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 unless the duration of activity for the treatment extends beyond this period
  • The patient has any other factor/reason which may, in the opinion of the Investigator, compromise participation and/or FU in the study.
  • Pregnant or lactating woman at the time of signing the ICF and prior to first AUP1602-C 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.
  • Current or previous (within 2 weeks prior to first AUP1602-C 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
  • Target ulcer other than non-healing DFU fulfilling inclusion criteria (e.g., including, but not limited to, pressure ulcers, burn wounds).
  • Ulcer of University of Texas Grade ≥ 3, with deep abscess, sinus track, necrosis or gangrene that cannot be removed by debridement.
  • Target ulcers with excessive exudation requiring more than one dressing change within 24 hrs at 1 st treatment visit (V1).
  • Target ulcers with clinically significant peri-wound skin maceration.
  • Target ulcer with known or suspected active infection, which requires antimicrobials
  • Women whose postmenopausal status has not been confirmed and last menstrual cycle was less than 12 months ago
  • Serum creatinine level of > 3.0 x ULN.
  • Prior radiation therapy (within 6 weeks prior to first AUP1602-C 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 colocated 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.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.