Clinical investigation to evaluate the performance and safety profile of a new dressing in the treatment of chronic, non-ischemic, non-healing diabetic foot ulcers, in association with the standard of care
| ISRCTN | ISRCTN11013503 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11013503 |
| Secondary identifying numbers | 20PL-GBT01311 |
- Submission date
- 24/03/2022
- Registration date
- 04/05/2022
- Last edited
- 30/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
IBSA Institut Biochimique S.A. (Lugano, Switzerland), the Sponsor of this study, have begun a clinical study on the medical device GBT013, a dressing for the treatment of chronic non-ischemic, non-healing diabetic foot ulcers. GBT013 already obtained CE certification in Europe (with the tradename Genmatrix®) and is approved for the treatment of chronic wounds, but it is not yet on the market. The aim of this study is to confirm the safety of the treatment with GBT013 for the intended usage, i.e. treatment of chronic wounds, in agreement with its currently approved Instructions For Use leaflet. The Sponsor is willing to conduct such a study in order to expand the clinical experience with the device.
Who can participate?
Patients aged 18 and over with diabetes and a chronic non-ischemic, non-healing foot ulcer
What does the study involve?
Participation in the study will last up to a maximum of 120 days (around 17 weeks) and participants will be asked to come to the clinical site for a maximum of 10 visits. The study consists of a screening period, which will start with the signature of the informed consent form. The screening period may last up to a maximum of 21 days (3 weeks) and includes questions and tests to determine whether subjects are eligible for the study. At the end of the screening period, if eligible for the study, participants will return to the clinical site to start the treatment with GBT013. The treatment period will last for a maximum of 70 days (12 weeks) and will be followed by 14 days (2 weeks) of follow up. From the screening period until the follow-up, a specialised nurse will visit subjects at home at least twice weekly to perform a medication change and check subjects’ compliance to the study requirements. It will take about 3 months to recruit all the subjects needed in this study and 4 months to evaluate all of them. This is a multicentre study, which means that the research will be carried out in various medical centres only in Poland and a total of 40 subjects will take part.
What are the possible benefits and risks of participating?
It cannot be confirmed that the study will help the participants but the information collected will help improve the treatment of people suffering from diabetic foot ulcers. The expected benefits consist of enhanced healing of the target ulcer treated with GBT013 and faster resolution of symptoms caused by the ulcer. Participants will receive evaluation and treatment for diabetic foot ulcers and will be supplied with an appropriate special boot to support the ulcer healing. Ulcer cleansing, complete debridement, secondary dressing therapy and GBT013 application will be provided on regular basis according to the study visit scheme included in the clinical investigational plan. One of the potential major advantages of GBT013 is the reduced number of applications needed for achieving complete ulcer healing. Based on the data available to date, a new application of GBT013 is necessary on average every 7 days for about 3 weeks. Furthermore, unlike other dressings, GBT013 may be left in place and layered if further applications are needed. This significantly minimizes interference with the wound, accelerating the healing process.
Where is the study run from?
IBSA Institut Biochimique (Switzerland)
When is the study starting and how long is it expected to run for?
February 2021 to May 2023
Who is funding the study?
IBSA Institut Biochimique SA (Switzerland)
Who is the main contact?
Serena Caverzasio, Serena.caverzasio@ibsa.ch
Contact information
Public
IBSA Institut Biochimique S.A.
Via del Piano 29
PO Box 266
Pambio-Noranco
6915
Switzerland
| Phone | +41 (0)583601000 |
|---|---|
| Serena.caverzasio@ibsa.ch |
Study information
| Study design | Multi-centre open-label prospective clinical investigation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | An open-label, multicentre, clinical investigation of the safety and performance of a new collagen-based, chondroitin sulfate- and chitosan-containing active wound care dressing, associated to standard of care, in the treatment of chronic, non-ischemic, non-healing diabetic foot ulcer |
| Study acronym | GBT013 |
| Study objectives | Laboratoires Genévrier (Antibes, France), currently IBSA Pharma SAS (France), a Sponsor’s subsidiary, developed a class III medical device, containing collagen, chitosan and chondroitin sulfate, i.e. GBT013 (product’s trademark in France: Genmatrix®), which received a CE certificate for the first time in November 2006, and subsequently reissued in May 2017, further revised in July 2019 and renewed in November 2020. The device has been initially CE-marked by equivalence to predicate devices of GBT013 (GBT013 CER rev2 2020) according to the MEDDEV 2.7.1 Rev 4, under the tradename of Proderm®. The aim of this clinical investigation is to confirm the safety of the treatment with GBT013 GBT013 for the intended usage, i.e. treatment of chronic wounds, in agreement with its currently approved Instructions For Use (IFU). |
| Ethics approval(s) | Approved 07/04/2021, Ethics Committee of Regional Medical Chamber in Łódź (3 Czerwona Str.,93-005 Łódź, Poland; +48 (0)42 683 17 44; Bioetyka@oil.lodz.pl), ref: K.B.–8/2021 |
| Health condition(s) or problem(s) studied | Chronic, non-ischemic, non-healing diabetic foot ulcer (DFU) |
| Intervention | The Implantable Medical Device (IMD) is a CE-certified product classified as a Class III medical device according to Directive 93/42/EEC and MDR 2017/745. The IMD is available as a sterile, single use, biocompatible and biodegradable dermal equivalent dressing (5 cm x 5 cm), manufactured by Laboratoires Genévrier (Antibes, France). GBT013 is a sterile, three-dimensional porous dressing, composed of collagen (72%), chitosan (20%) and chondroitin sulfate (8%). Type I collagen 1% gel is of equine, chondroitin sulfates of porcine and chitosan of squid origin. It is intended for topical use. This study is a post-market investigation the Sponsor is willing to conduct in order to expand the clinical experience with the IMD and confirm its safety and performance when used according to its CE certification. Overall, subject participation in the study will last up to a maximum of 120 days (around 17 weeks) and subjects will be asked to come to the clinical site for a maximum of 10 visits. The study consists of a screening period, which will start with the signature of the informed consent form. The screening period may last up to a maximum of 21 days (3 weeks) and includes questions and tests to determine whether subjects are eligible for the study. At the end of the screening period, if eligible for the study, subjects will return to the clinical site to start the treatment with GBT013. The treatment period will last for a maximum of 70 days (12 weeks) and will be followed by 14 days (2 weeks) of follow up. From the screening period until the follow-up, a specialised nurse will visit subjects at home at least twice weekly to perform a medication change and check subjects’ compliance with the study requirements. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | GBT013 |
| Primary outcome measure | Safety of the IMD assessed using the incidence of adverse events (AEs) and, specifically, treatment-emergent AEs (TEAEs) occurring at any time during the study (Common Terminology Criteria for Adverse Events v.5.0) (incidence, severity, duration, and causal relationship with the investigational product (IP) assessment) |
| Secondary outcome measures | Safety of the IMD assessed using: 1. Treatment-related TEAEs (i.e., adverse device effects [ADEs]) and serious TEAEs occurring at any time during the study 2. Infection incidence at the target ulcer and duration (days) of systemic antibiotherapy 3. Incidence of limb amputation (minor and major) needed at any time during the study 4. Overall treatment tolerability, independently judged by the Investigator and subject using a 5-point scale (4 = excellent; 3 = good; 2 = fair; 1 = poor; 0 = none) at the end of the study 5. Vital signs (systolic blood pressure, diastolic blood pressure, heart rate) measured at each visit (from screening to visit 9 and follow up visit) 6. Serum creatinine, ALT, complete blood count, and proteinuria measured at screening and Visit 9 7. Subject’s exposure (mean number of IP dressings used) during the whole study period Performance of the IMD assessed using: 1. Proportion (%) of target ulcers closed ≤12 weeks (ITT) (defined as 100% re-epithelialization and no drainage) and confirmed at the follow-up visit 2 weeks later, as assessed by the investigators at the investigational site 2. Percent (%) reduction of the wound area measured with a standardised digital picture and validated image analysis software at each control visit 3. Time (days) elapsed from the first IP application until complete ulcer closure, defined as 100% re-epithelialization and no drainage 4. Overall treatment performance (easiness of IP manipulation, IP efficacy), judged by the Investigator using a 5-point scale (4 = excellent; 3 = good; 2 = fair; 1 = poor; 0 = none) at the end of the study Subject’s assessment of their quality of life and their satisfaction with the treatment assessed using: 1. Subject’s quality of life (QoL) assessed by the subject using the SF-36 questionnaire at the screening visit and visit 9 2. Treatment satisfaction judged by the subject using a 5-point scale (4 = excellent; 3 = good; 2 = fair; 1 = poor; 0 = none) at the end of the study |
| Overall study start date | 18/02/2021 |
| Completion date | 15/05/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Adult male and female outpatients aged ≥18 years 2. Subject being diagnosed with type 1 or type 2 diabetes 3. Subject diagnosed with plantar neuropathic DFU (positive Semmes-Weinstein 10 g Monofilament test) 4. Chronic DFU present from ≥4 weeks and ≤ 24 weeks 5. DFU cross-sectional area of ≥1 cm² and ≤10 cm² 6. DFU of grade 1A-1B or 2A-2B according to the University of Texas Staging System for Diabetic Foot Ulcers 7. DFU Grade 1/uninfected or Grade 2/mild infected according to Infectious Diseases Society of America (IDSA) classification 8. Glycated haemoglobin HbA1c value ≤9% at Screening or within 3 months prior to inclusion 9. Presence of dorsalis and posterior tibial pulses and Ankle-Brachial Pressure Index (ABPI) value ≥0.9 and ≤1.2 at Screening or within 3 months prior to inclusion 10. No surgery at the limb of interest within 1 month prior to inclusion 11. Performance status Eastern Cooperative Oncology Group (ECOG) 0-1 12. Subject provided written informed consent to participate in the study obtained according to Good Clinical Practice (GCP) 13. Subject able to comprehend the full nature and the purpose of the study, including possible risks and side effects, and subjects able to cooperate with the Investigator and to comply with the requirements of the entire study (including the ability to attend all the planned study visits according to the time limits, have access to the internet via a computer, iPad, iPhone or Android device), based on Investigator’s judgement 14. Females of childbearing potential (i.e., not permanently sterilised - post-hysterectomy or tubal ligation status – or not postmenopausal) must have a negative pregnancy test result at Screening and must use an appropriate method of contraception for at least 30 days before inclusion in the study and during the whole study period, according to the definition in ICH M3 Guideline: a highly effective method is defined as those which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. |
| Key exclusion criteria | 1. DFU of ischemic or neuroischemic origin (ABPI <0.9) 2. DFU which cross-sectional area diminished >30% during the 2-week run-in period of the study, i.e. between V1 and V2 3. Infected DFU at the end of the run-in period, i.e. V2 4. Superinfected DFU (Grade 3-4 according to IDSA classification) including osteitis 5. Presence of necrotic tissue on the target DFU bed 6. DFU with exposed tendon or bone 7. Active Charcot’s foot 8. Presence of more than one plantar DFU in the limb of interest 9. Presence of plantar DFUs in both limbs Treatment-specific exclusion criteria: 10. Concomitant treatment or treatment within 3 months prior to the enrolment with medications known to adversely affect the healing process or suspected of compromising the subject's immune system: i.e., systemic corticosteroids, cytostatic drugs, immunosuppressive agents 11. Treatment with topical antibiotics in the target wound area 12. Allergy to components contained in the IP 13. History of anaphylaxis or allergic reactions to any other allergens potentially affecting the study outcome General exclusion criteria: 14. Clinically significant or unstable underlying/concurrent disease whose sequelae or treatment might interfere with the evaluation of study parameters, including autoimmune diseases, such as rheumatoid arthritis, vasculitis; immunocompromised states, such as HIV infection 15. Severe anemia (haemoglobin <8 g/dl) or hypoalbuminemia (albumin <2.5 g/dl) indicating a poor nutritional status (<3 months prior to inclusion) 16. Subject suffering from severe hepatic disorders (with serum activity of ALT/AST ≥2.5 UNL) or severe renal disorders (creatinine clearance <30 ml/min) (<3 months prior to inclusion) 17. Presence of severe cardiac/cardiovascular conditions, i.e. NYHA Class III and IV congestive heart failure (CHF) 18. Subjects with a history of alcohol or drug abuse (within the previous 12 months), or heavy smoker (>25 cigarettes/day) 19. Major psychiatric disorders that, in the view of the Investigator, could compromise the patient’s participation in the study 20. Positive or missing pregnancy test at the screening visit, or breastfeeding women 21. Concomitant participation in other clinical trials or participation in the evaluation of any IMDs/IMPs during 3 months before this study or previous participation in the same study 22. Participation in the study is also not permitted to employees of the Investigator or study centre with direct involvement in the trial or in other trials under the direction of that Investigator, as well as family members of the employees or the Investigator |
| Date of first enrolment | 30/09/2021 |
| Date of final enrolment | 30/11/2022 |
Locations
Countries of recruitment
- Poland
Study participating centres
Łódź
94-238
Poland
Ostróda
14-100
Poland
Warszawa
02-954
Poland
Chojnice
89-600
Poland
Malbork
82-220
Poland
Lublin
20-064
Poland
Świnoujście
72-600
Poland
Jaksice
88-181
Poland
Sponsor information
Industry
Via del Piano, PO Box 266
Pambio Noranco
CH-6915
Switzerland
| Phone | +41 (0)583601000 |
|---|---|
| carol.caverzasio@ibsa.ch | |
| Website | https://www.ibsagroup.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
30/07/2024: The contact was changed.
18/07/2023: Medsearch Institute has been added to the trial participating centres.
30/08/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/08/2022 to 30/11/2022.
2. The overall trial end date has been changed from 31/01/2023 to 15/05/2023 and the plain English summary updated accordingly.
3. Oświęcimskie Centrum Badań Klinicznych MEDICOME Sp. z o.o. and Centrum Usług Medycznych MaxMed were removed from the trial participating centres and NZOZ NEUROMED M. i M. Nastaj Spółka Partnerska and Balticmed Świnoujście were added.
31/03/2022: Trial's existence confirmed by the Ethics Committee of Regional Medical Chamber in Łódź.
