| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Chronic diabetic foot ulcers |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10012664 |
| E.1.2 | Term | Diabetic foot ulcer |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To compare the efficacy of three concentrations of I-020201 as adjunct topical treatment to good standard-of-care on the wound healing versus good standard-of-care alone in patients with chronic diabetic foot ulcers. |
|
| E.2.2 | Secondary objectives of the trial |
- To assess the safety and tolerability of I-020201 in the treatment of chronic diabetic foot ulcers
- To assess systemic PDGF-AB levels and antibodies against TG-PDGF.AB
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. male or female, aged ≥ 18 years
2. given written informed consent
3. female of childbearing potential with a negative result from the pregnancy test at screening who agrees to use an acceptable birth control method (hormonal or IUD) or abstinence throughout the trial
4. Type 1 or Type 2 Diabetes mellitus with HbA1c < 10%
5. with only one diabetic foot ulcer on the foot to be treated on or below the ankle meeting the following criteria:
- having persisted for more than 4 weeks despite adequate treatment (debridement when necessary, wound dressing that maintain a moist wound-healing environment, off-loading including crutches, walkers, wheelchairs, custom shoes, depth shoes, shoe modifications, custom inserts, custom relief orthotic walkers, diabetic boots, forefoot and heel relief shoes, and total contact cast)
- free of necrotic tissue after major (excisional) debridement as per protocol
- size between 1 and 10 cm2 after major (excisional) debridement as per protocol at screening
- grade 1 or 2 of the Wagner diabetic foot ulcer classification
6. patients must be willing to:
- comply with treatment application instructions
- wear off-loading shoes as instructed
- continue to use appropriate therapeutic footwear after complete wound closure until the study end
- adhere to the study requirements or have adequate caretaker assistance
7. appropriately communicative to verbalize discomfort
8. capable of understanding and complying with study protocol requirements
|
|
| E.4 | Principal exclusion criteria |
1. pregnant or breast-feeding
2. known or suspected allergies to any of the components of I-020201
3. uncontrolled anemia (Hb < 10 g/dL in females and < 12 g/dL in males)
4. hypoalbuminemia (albumin < 3 g/dL)
5. overtly infected target ulcer (as judged by investigator)
6. highly exuding wounds (wounds that require a daily dressing change)
7. osteomyelitis
8. systemic infections
9. acute Charcot foot and severe chronic Charcot deformity:
- Classically, an acute Charcot foot is painless with warmth, erythema, and edema in the presence of diabetic neuropathy. It may be difficult to differentiate from cellulitis. Patients may experience moderate pain and discomfort.
- Long standing Charcot deformity with midfoot collapse and rocker contour of the plantar surface of the foot is a severe deformity.
10. ABPI < 0.7 or ankle systolic pressure < 70 mm Hg
11. one of the following findings:
- on Doppler waveform analysis on the dorsalis pedis and posterior tibial arteries a monophasic or biphasic flow (with loss of reverse flow) in either foot artery, or
- a toe: brachial index < 0.7, or
- transcutaneous oxygen pressure (TcpO2) < 40 mm Hg
Not all 3 tests need to be performed; only one is required. Wherever possible, the measurement of TcpO2 is preferred over the former two.
12. skin changes ascribed to venous disease (e.g. stasis eczema, dermatoliposclerosis) with or without active ulceration
13. suspicion, presence or history of systemic or local cancer or tumor of any kind
14. known immunodeficiency disorders, either congenital or acquired.
15. chronic treatment with immunosuppressives or systemic corticosteroids within the last 2 months prior to treatment start
16. use of topical antibiotics, enzymatic debriders or ointments containing heavy metals on the target ulcer within 1 week to treatment start and during the trial
17. previous exposure to PDGF-BB (becaplermin – Regranex®)
18. previous exposure to Apligraf® or other commercially available artificial skin grafts within the last 6 weeks
19. revascularization surgery or procedures within the last 4 weeks (e.g. PTA)
20. known clinically significant organ or systemic diseases, such that, in the opinion of the investigator, the significance of the disease will compromise the patient’s participation in the study
21. suspected alcohol or drug abuse
22. participation in another investigational study within 30 days prior to treatment start, for investigational devices, or within the last three months for investigational drugs related to wound healing
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Percent reduction in ulcer surface area from baseline (BL) (Visit 2) to 4 weeks after treatment start. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| Vehicle: 2 ml fibrin foam |
|
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 17 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
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