Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Decellularized Dermis (DermACELL AWM®): Applied on Day 0 and follow up from Week 1 to 16
Control Intervention1: Not applicable: Not applicable
Sponsors
LifeNet Health Inc
PharmaLeaf India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Chronic Lower Extremity Wounds: 1. Be male or female between ages 18 and 65 at the time of consent. 2. Have full-thickness wound on the lower extremity. If the target wound is a DFU, the ulcer extension may involve ligament, tendon, joint capsule, or fascia, without presence of abscess or osteomyelitis. If the target wound is a VSU, the wound should be an open ulcer without presence of abscess or infection. 3. Have a wound with an area greater than or equal to 1cm2 and less than 25 cm2 and a depth less than or equal to 9 mm. 4. Have a target wound that has been present for at least 30 days. 5. Have an absence of infection based upon Investigator examination. 6. Have adequate circulation to the affected lower extremity based upon Investigator examination. (Ankle-brachial index (ABI) assessed at the Screening visit should range between 0.8 and 1.2.) 7. Have the ability to comply with clinic visit schedule, off-loading (DFU), compression dressings (VLU) and dressing change requirements. Traumatic Burn: 1. Be male or female between ages 18 and 65 at the time of consent. 2. Have full-thickness burn without presence of abscess or infection. 3. Have a target burn area greater than or equal to 1cm2 and less than 25 cm2. 4. Have the ability to comply with scheduled clinic visits and dressing change requirements Dehisced Surgical Wound: 1. Be male or female between ages 18 and 65 at the time of consent. 2. Have a dehisced surgical wound that is not amenable to re-suturing. 3. Have a target wound area greater than or equal to 1cm2 and less than 25 cm2. 4. Have the ability to comply with scheduled clinic visits and dressing change requirements
Exclusion criteria
Exclusion criteria: Chronic Lower Extremity Wounds: 1. Be pregnant or lactating. 2. Have circulating hemoglobin A1c exceeding 9%. 3. Have kidney or liver impairment that may impact wound healing. 4. Have had the wound treated with a skin substitute (Integra® BiLayer Wound Matrix, Apilgraft®, porcine dermis, bovine dermis) or topical growth factors within the previous 30 days before the screening visit. 5. Have clinical signs of an infection at the study wound site. 6. For DFU, have the inability to tolerate off-loading. 7. For VSU, have the inability to tolerate multiple layer compression dressings. 8. Have a known or suspected disease of the immune system. 9. Have an active or untreated malignancy or active, uncontrolled connective tissue disease. 10. Had a treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before the baseline visit. 11. Have presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement. 12. Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb less than 4 weeks before the baseline visit. 13. Have active Charcot disease. 14. Have ongoing evidence of peripheral vascular disease, including greater than one nonpalpable pulse on either foot. 15. Have the presence of any condition that in the opinion of the physician places the patient at undue risk or potentially jeopardizes the quality of the data to be generated. Traumatic Burn: 1. Be pregnant or lactating. 2. Have kidney or liver impairment that may impact healing. 3. Have had the burn treated with a skin substitute (Integra® BiLayer Wound Matrix, Apilgraft®, porcine dermis, bovine dermis). 4. Have clinical signs of an infection at the burn site. 5. Have a known or suspected disease of the immune system. 6. Have an active or untreated malignancy or active, uncontrolled connective tissue disease. 7. Had a treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before the baseline visit. 8. Have presence of necrosis or purulence that cannot be removed by debridement. 9. Have the presence of any condition that in the opinion of the physician places the patient at undue risk or potentially jeopardizes the quality of the data to be generated. Dehisced Surgical Wound: 1. Be pregnant or lactating. 2. Have kidney or liver impairment that may impact healing. 3. Have had the wound treated with a skin substitute (Integra® BiLayer Wound Matrix, Apilgraft®, porcine dermis, bovine dermis). 4. Have clinical signs of an infection at the wound site. 5. Have a known or suspected disease of the immune system. 6. Have an active or untreated malignancy or active, uncontrolled connective tissue disease. 7. Had a treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before the baseline visit. 8. Have presence of necrosis or purulence that cannot be removed by debridement. 9. Have the presence of any condition that in the opinion of the physician places the patient at undue risk or potentially jeopardizes the quality of the data to be generated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety will be measured across all wound types by the incidence of treatment-emergent AEs, changes in vital signs, ABI (lower extremity wound group), and physical examination.Timepoint: Day 0 to Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to wound closure measured from baseline to termination visit (16 weeks). The rate of wound infection (wounds will be classified as infected when a culture contains 105 or greater microorganisms). Percent of wounds requiring a second application of DermACELL AWMTimepoint: Day 0 to Week 16 | — |
Countries
India
Contacts
Public ContactVinay Tallapally
PharmaLeaf India Private Limited
Outcome results
None listed