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)

Ki vehet részt

• 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
• 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)

Ki nem vehet részt

• 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 has received skin substitutes during the screening period or within 14 days prior to beginning of screening period
• Hgb A1c > 12 percent within 3 months prior to randomization
• 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
• 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 has received skin substitutes during the screening period or within 14 days prior to the beginning of the screening period
• Hgb A1c > 12 percent within 3 months prior to randomization in patients with a known history of diabetes
• 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
• Participant unwilling or unable to tolerate use of compression therapy for the duration of the study
• Participant has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
• 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
• Active infection, undrained abscess, or critical colonization of the wound(s) with bacteria in the judgment of the investigator
• 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
• 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 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
• Active infection, undrained abscess, or critical colonization of the wound(s) with bacteria in the judgment of the investigator
• 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
• Participant is pregnant, breast feeding or planning to become pregnant
• Participant has a life expectancy less than six months as assessed by the investigator
• Participant has an additional wound within 3 cm of the study wound(s) or study wounds are less than 3 cm apart
• Participant not in reasonable metabolic control 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)
• Participant is pregnant, breast feeding or planning to become pregnant
• Participant has a life expectancy less than six months as assessed by the investigator
• Participant has an additional wound within 3 cm of the study wound or study wounds are less than 3 cm apart
• Participant is not in reasonable metabolic control in the judgment of the investigator