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Diabetic Foot UlcerPhase 1/2NCT04281992

Treatment of Diabetic Foot Ulcers With AUP1602-C

A Phase 1/2 study testing AUP1602-C in people with Diabetic Foot Ulcer, run by Aurealis Oy at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a two-part phase 1/2A study performed in diabetic foot ulcer (DFU) patients with chronic non-healing wounds to investigate the safety and efficacy of AUP1602-C. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetic Foot Ulcer
What is being tested?
AUP1602-C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
2 sitesin 2 countries
Study dates
28 Jan 2020to 20 Mar 2023
Phase
Phase 1/2
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients aged 18 to 80 years
  • Patients with DM of type 1 or 2 having a glycosylated haemoglobin (HbA1c) of ≤11% and a serum creatinine level of ≤1.5 times the upper limit of normal (ULN)
  • Patients with at least one ulcer that fulfills all of the following criteria at screening and at baseline (prior to treatment start)
  • Present for ≥1 month
  • Located either in the plantar or on the dorsum of foot, or in the distal part of the leg, around the malleolar areato be accessible for administration of AUP1602-C/placebo and to be completely covered by the primary and secondary dressings
  • Partial- or full-thickness, not involving bone or joints, i.e. University of Texas classification Grade 1A, 1C, 2A or 2C.
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  • No clinical signs of active infection or osteomyelitis
  • Size of the target ulcer for DFU must be between 1-9 cm2 after debridement
  • Chronic target ulcer, defined as <30% reduction in size in response to SoC during the 2-week screening period
  • Target ulcer appropriately debrided (<10% black and at least 50% of red/pink on a colorimetric scale)
  • Ulcer and periwound tissue suitable to using film dressings (i.e. no contraindications [e.g.: excessive exudation, maceration] 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 5 cm healthy tissue but only one target ulcer will be selected for the investigational treatment (based on investigator decision)
  • Patients with an ankle brachial index (ABI) ≥0.7 on the foot with the target ulcer
  • Patients with an assessment of the baseline level of neuropathy of the foot using Semmes-Weinstein monofilaments
  • Patients must adhere to wear therapeutic shoes or off-loading footwear if indicated
  • A female patient of childbearing potential must have a negative serum pregnancy test at the time of Screening
  • Patients must use a highly effective contraceptive measure (methods that can achieve a failure rate of less than 1% per year when used consistently and correctly), like hormonal contraception (oral pills, implantable device, or skin patch), intrauterine device, bilateral tubal occlusion, or double barrier 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

  • Current or previous (within 2 weeks prior to start of screening/run-in period) treatment with another investigational drug and/or medical device or participation in another clinical study
  • Current or previous (within 30 days prior to start of screening/run-in period) treatment with a biologic agent, growth factors or skin equivalents (e.g. Regranex®, Apligraf®, or Dermagraft®)
  • Current or previous (within 2 weeks prior to first study drug dosing) treatment with active wound care agents (e.g. local and systemic antibiotics or silver dressings)
  • Current or previous (within 2 weeks prior to first study drug dosing) use of corticosteroids and immunosuppressants
  • Known hypersensitivity to any of the investigational drug or vehicle components
  • Ulcer of University of Texas Grade ≥2, with deep abscess, or gangrene
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  • Target ulcer with known or suspected active infection which requires antimicrobials. Any antibiotic therapy must be completed or discontinued within 2 weeks prior to first study drug dosing
  • Target ulcer positive for MRSA
  • Target ulcer other than chronic non-healing DFU (e.g. pressure ulcers, burn wounds)
  • Prior radiation therapy (within 6 weeks prior to first study drug dosing) of any part of the foot/leg bearing the target ulcer under study
  • Sickle-cell anemia, Reynaud's, or other peripheral vascular disease including venous leg ulcers
  • Infective endocarditis or increased risk for infective endocarditis, which includes, but is not limited to, prosthetic cardiac valve or prosthetic material used for cardiac valve repair, previous infective endocarditis, congenital heart disease, and cardiac transplantation recipients who develop cardiac valvulopathy, history of rheumatic fever or rheumatic heart disease diagnosed by echocardiogram, or history (within 10 years prior to enrollment) of IV drug abuse
  • Active Charcot deformity of the study foot (i.e. foot is erythematous, warm, edematous, and is actively remodeling)
  • Patients with other reasons for wound healing disturbances: e.g. bleeding disorders, vitamin K deficiency, hypocalcemia, 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, was treated and is currently disease-free and not on active treatment with an immune-suppressive therapy at least for 3 months, may be considered for study entry
  • Pregnant or lactating woman
  • Haemoglobin of less than 8.5 g/dL
  • Transaminase levels greater than 3 times ULN
  • Patients receiving haemodialysis or chronic ambulatory peritoneal dialysis (CAPD) therapy
  • Positive for hepatitis B or C virus (HBV, HCV), or human immunodeficiency virus (HIV); serology test results not older than 3 months are accepted
  • Planned surgery during the study period
  • Known abuse of alcohol, drugs, or medical products. Tobacco use will be allowed
  • Previous participation in this clinical study
  • Any diagnosed unstable condition that could interfere with compliance, such as psychiatric disorder
  • Myocardial infarction diagnosed within last 3 months prior to start of screening/run-in period
  • Confirmed or suspected COVID-19 infection.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Germany1 site

  • Medizinische Hochschule Hannover (MHH) CRC Core Facility

    Hanover

Other trials in Germany

Poland1 site

  • Mikomed

    Lodz

Other trials in Poland

About this study

Official title: A Phase 1/2A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Single and Repeated Doses of AUP1602-C as Topical Treatment of Diabetic Foot Ulcers

This is a two-part phase 1/2A study performed in diabetic foot ulcer (DFU) patients with chronic non-healing wounds to investigate the safety and efficacy of AUP1602-C.

Read the detailed description

Study AP-W-CLI-2018-8 is the first clinical study of AUP1602-C in humans. It is a Phase 1/2A clinical study to evaluate the safety, tolerability and efficacy of a single and repeated doses of AUP-16 as topical treatment of DFU. The Phase 1 part will be a multicenter, open-label, non-randomized, uncontrolled dose-finding study with sequential dose escalations performed in dose cohorts comparing three doses of AUP-16 administered three times per week (low, medium, and high dose cohorts). This part will consist of four sequentially recruited cohorts. It is expected that a minimum of 15 patients may be required to determine the RP2D in phase 1 part.

The Phase 2A part, an extension of the Phase 1, will be a multi-center, open-label, randomized, placebo-controlled study of the recommended AUP1602-C dose and administration schedule from Phase 1 to confirm safety and to assess efficacy of the selected recommended phase 2 dose and schedule in DFU patients.

Being tested
AUP1602-C
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.

Study groups in NCT04281992
Study groupRoleWhat they receive
AUP1602-CExperimentalAUP1602-C will be administered topically once or repeatedly three times per week during the treatment period.
Receives: Biological: AUP1602-C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs) and potential dose-limiting toxicities (DLTs)

    Incidence of adverse events (AEs) and potential dose-limiting toxicities (DLTs) for safety, low, medium, and high dose cohorts of single and repeatedly administered AUP1602-C

    Measured: 4 weeks

  2. Incidence of Treatment-Emergent Adverse Events

    • Incidence of AEs

    Measured: 6 months

  3. Incidence of Wound Closure

    • Percentage (%) of patients with a target ulcer achieving complete wound closure
    • Percentage (%) of wound size reduction (wound area measurements in cm^2)

    Measured: 6 months

Secondary outcomes (9)

  1. Incidence of Wound Closure

    • Percentage (%) of wound area (cm^2) reduction
    • Percentage (%) of wound depth (mm) reduction
    • Percentage (%) of wound volume (mm^3) reduction

    Measurements will be aggregated: Wound are and depth will be used to calculate wound volume.

    Measured: 6 months

  2. Incidence of ulcer recurrence

    Percentage (%) of patients with ulcer recurrence

    Measured: 6 months

  3. Incidence of Wound Infections

    Proportion of patients with local wound infections related to the target ulcer

    Measured: 6 months

  4. Incidence of surgical procedures

    • Number of patients with local surgical procedures
    • Incidence of amputations (minor or major) related to the target ulcer

    Measured: 6 months

  5. 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: 6 months

  6. 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: 6 months

  7. 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: 6 months

  8. Incidence of Adverse Events

    • Incidence of abnormal vital signs
    • Incidence of abnormal ECG data
    • Incidence of abnormal echocardiogram data
    • Incidence of abnormal ophthalmoscopy data
    • Incidence of abnormal physical examination findings
    • Incidence of abnormal laboratory data

    Measured: 6 months

  9. Incidence of bacteria distribution

    Assessment of biodistribution and shedding (yes / no)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2020
  2. Study start28 Jan 2020
  3. Primary completion20 Mar 2023
  4. Study completion20 Mar 2023

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Analyses for phase 1 part will be done by cohort and analyses for phase 2A part will be done by treatment arms.
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04281992
Sponsor's protocol ID
AP-W-CLI-2018-8
Other IDs
2018-003415-22, 2018
Status last verified
Sep 2023
First submitted
14 Feb 2020
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Schindler C, Mikosinski J, Mikosinski P, Karkkainen HR, Sanio M, Kurkipuro J, Mierau I, Smith W, Vartiainen A, Decory L, Weber D, Wirth T, Yrjanheikki J, Schellong S, Samaranayake H. Multi-target gene therapy AUP1602-C to improve healing and quality of life for diabetic foot ulcer patients: a phase I, open-label, dose-finding study. Ther Adv Endocrinol Metab. 2024 Nov 4;15:20420188241294134. doi: 10.1177/20420188241294134. eCollection 2024.

    PubMed 39838970

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AUP1602-C in people with Diabetic Foot Ulcer, run by Aurealis Oy at 2 sites in 2 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 18 inclusion and 26 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 28 Sep 2023. 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 Germany, Poland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 adverse events (AEs) and potential dose-limiting toxicities (DLTs) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04281992, which also lists 1 linked publication.

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 28 Sep 2023.

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Treatment of Diabetic Foot Ulcers With AUP1602-C | AzTrials