EUCTR2006-005128-18-CZ进行中（未招募）不适用
A randomized, multi-center, controlled, parallel group, dose finding study of the efficacy and safety of topically applied I-020201 as an adjunct to good standard-of-care versus good standard-of-care alone in patients with chronic diabetic foot ulcers - N/A
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 = 12%
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. pregnant or breast-feeding
- •2. known or suspected allergies to any of the components of I-020201
- •3. uncontrolled anemia (Hb < 9 g/dL in females and < 10 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
研究者
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