NCT04927702终止不适用
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- For Diabetic Foot Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound
研究概览
简要总结
In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care.
In participants with venous leg ulcers (VLUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with living cellular skin substitute (Apligraf®)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Participants with Diabetic Foot Ulcers:
- •Participant is at least 18 years old
- •Participant is willing and capable of complying with all protocol requirements
- •Participant or legally authorized representative (LAR) is willing to provide written informed consent
- •Participant has Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association)
- •Ulcer(s) must be located at least in part on the foot or ankle
- •Ulcer(s) must be present for more than 28 days prior to randomization and initial application of study product, and has not adequately responded to conventional ulcer therapy
- •Wound size must be >1.0 cm^2 and < 25 cm^2 on the day of randomization and initial application of the study product, after initial debridement
- •Participant has adequate circulation to the affected extremity(ies), as demonstrated by at least ONE of the following within 60 days prior to enrollment/randomization:
- •Dorsum transcutaneous oxygen test (TcPO2) of study leg(s) with results ≥40mmHg, OR
- •Ankle-Brachial Index (ABI) of study leg(s) with results of ≥ 0.7 and ≤ 1.3, OR
- •Toe-Brachial Index (TBI) of study extremity(ies) with results of ≥ 0.5
排除标准
- •for Participants with Diabetic Foot Ulcers:
- •Participant has been previously enrolled into this study, or is currently participating in another prospective drug or device study that has not reached its primary endpoint
- •Participant is pregnant, breast feeding or planning to become pregnant
- •Participant has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
- •Participant has a life expectancy less than six months as assessed by the investigator
- •Participant has received skin substitutes during the screening period or within 14 days prior to beginning of screening period
- •Participant has an additional wound within 3 cm of the study wound(s) or study wounds are less than 3 cm apart
- •Hgb A1c > 12 percent within 3 months prior to randomization
- •Participant not in reasonable metabolic control in the judgment of the investigator
- •Participant with a known history of poor compliance with medical treatments
- •Participant currently undergoing cancer treatment
- •Participant has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
- •Participant is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the screening period or up to 30 days before the screening period. Chronic oral steroid use is not excluded if dose is < 10 mg per day for prednisone.
- •Active infection, undrained abscess, or critical colonization of the wound(s) with bacteria in the judgment of the investigator
- •Osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence
- •Participant unwilling or unable to safely utilize appropriate offloading device to unweight wound(s)
- •Study ulcer(s) experiences greater than 30 percent reduction over the 2-week screening period
- •Participant also has a venous leg ulcer that is enrolled into this study
- •Inclusion Criteria for Participants with Venous Leg Ulcers:
- •Participant is at least 18 years old
- •Participant is willing and capable of complying with all protocol requirements
- •Participant or legally authorized representative (LAR) is willing to provide written informed consent
- •Participant has peripheral venous disease per investigator judgment or diagnostic confirmation
- •Ulcer(s) must be venous in origin, located on a lower extremity
- •Ulcer(s) must be present for more than 28 days prior to randomization and initial application of study product, and has not adequately responded to conventional ulcer therapy
- •Wound(s) size must be >1.0 cm^2 and < 50 cm^2 on the day of randomization and initial application of the study product, after initial debridement
- •Participant has adequate circulation to the affected extremity(ies), as demonstrated by at least ONE of the following within 60 days prior to enrollment/randomization:
- •Dorsum transcutaneous oxygen test (TcPO2) of study leg(s) with results ≥ 40mmHg, OR
- •Ankle-brachial index (ABI) of study leg(s) with results of ≥ 0.7 and ≤ 1.52, OR
- •Toe-Brachial Index (TBI) of study leg(s) with results of ≥ 0.5, OR
- •Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected leg(s)
- •Exclusion Criteria for Participants with Venous Leg Ulcers:
- •Participant has been previously enrolled into this study, or is currently participating in another prospective drug or device study that has not reached its primary endpoint
- •Participant is pregnant, breast feeding or planning to become pregnant
- •Participant has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
- •Participant has a known allergy to bovine materials or agarose shipping materials
- •Participant has a life expectancy less than six months as assessed by the investigator
- •Participant has received skin substitutes during the screening period or within 14 days prior to the beginning of the screening period
- •Participant has an additional wound within 3 cm of the study wound or study wounds are less than 3 cm apart
- •Hgb A1c > 12 percent within 3 months prior to randomization in patients with a known history of diabetes
- •Participant is not in reasonable metabolic control in the judgment of the investigator
- •Participant has a known history of poor compliance with medical treatments
- •Participant currently undergoing cancer treatment
- •Participant has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
- •Participant is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the screening period or up to 30 days before the screening period. Chronic oral steroid use is not excluded if dose is < 10 mg per day for prednisone.
- •Active infection, undrained abscess, or critical colonization of the wound(s) with bacteria in the judgment of the investigator
- •Participant unwilling or unable to tolerate use of compression therapy for the duration of the study
- •Study ulcer(s) experiences greater than 30 percent reduction over the 2-week run-in period
- •Participant also has a diabetic foot ulcer that is enrolled into this study
研究组 & 干预措施
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
Experimental
Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
干预措施: Synthetic Hybrid-Scale Fiber Matrix (Device)
Diabetic Foot Ulcer Participants Assigned to Standard of Care
Active Comparator
Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
干预措施: Standard of Care (Device)
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
Experimental
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
干预措施: Synthetic Hybrid-Scale Fiber Matrix (Device)
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)
Active Comparator
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
干预措施: Living Cellular Skin Substitute (Device)
结局指标
主要结局
For Diabetic Foot Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound
时间窗: 12 weeks
The number of wounds in each treatment arm that achieved 100 percent epithelialization of wound as assessed by a blinded evaluator via review of a three-dimensional high resolution photo of the wound plus confirmation of no drainage or need for additional dressing 2 weeks after 100 percent epithelialization
For Venous Leg Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound
时间窗: 16 weeks
The number of wounds in each treatment arm with 100 percent epithelialization of wound as assessed by a blinded evaluator via review of a three-dimensional high resolution photo of the wound plus confirmation of no drainage or need for additional dressing 2 weeks after 100 percent epithelialization
次要结局
- Percentage Change in Wound Area(Weekly assessments for 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first.)
- Time to 100 Percent Epithelialization(12 weeks for DFU wounds (16 weeks for VLU wounds), or until 100 percent epithelialization, whichever occurs first.)
- Total Number of Product Applications(Initial application until 12 weeks for DFU patients and 16 weeks for VLU patients, or until 100% re-epithelialization, whichever occurs first)
研究者
研究点 (6)
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