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This is a prospective, randomized, single-site, safety and efficacy study of subjects with chronic venous stasis ulcers. Patients will fall into two categories: treatment arm (24 subjects) and non-treatment or control arm (12 subjects). The treatment group will undergo a small liposuction procedure and receive placement of autologous cell therapy (stromal vascular fraction or SVF) injected around the rim of venous stasis wound (subcutaneously)following standard wound debridement, with saturation of collagen dressing material with standard over-dressing. Control (non-treatment) subjects will receive debridement and dressing changes as per standard of care without SVF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transpose ® RT System | Experimental | Adipose-derived stem cells (also known as stromal vascular fraction or SVF) will be injected subcutaneously around the rim of the wound bed following standard would debridement. The standard collagen dressing material will also be saturated with SVF after placement within the would itself. Normal (standard) dressing of wound will be placed over wound. |
|
| debridement/dressing of wound | Active Comparator | Wound will be debrided and collagen dressing placed within wound bed as per standard of care. Standard dressing will cover wound. No adipose-derived stem cells (SVF) will be applied to control subject wounds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transpose ® RT System | Device | adipose-derived stem cell therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: as indicated through adverse event rate between control versus experimental group | adverse event rate | enrollment through 12 months of follow-up |
| Time to complete wound closure as evidenced by complete epithelialization over a one-year time period (efficacy) | time it takes for complete wound closure following procedure | enrollment through 12 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in wound area over time (wound healing velocity) | size of wound will become smaller as measured during follow-up visits | enrollment through 12 months of follow-up |
| Percent decrease in wound size (length X width X depth) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley K Coots, M.D. | Sanford Plastic and Reconstructive Surgery- Sioux Falls, SD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanford USD Medical Center | Sioux Falls | South Dakota | 57105 | United States |
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| ID | Term |
|---|---|
| D014949 | Wounds, Nonpenetrating |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D003646 | Debridement |
| D001458 | Bandages |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D004864 | Equipment and Supplies |
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this study utilizes a medical device
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| debridement/dressing of wound |
| Other |
standard of care debridement and wound dressing |
|
wound size will decrease when measured at follow-up visits
| enrollment through 12 months of follow-up |
| Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life | patient will report better health outcomes using quality of life questionnaires | enrollment through 12 months of follow-up |
| Assessment of overall health status (questionnaire 36-Item Short Form/SF-36) | patient will report better health outcomes using quality of life questionnaires | enrollment through 12 months of follow-up |
| assessment of disease specific quality of life (questionnaire: CIVIQ-20) | quality of life as it relates to lower extremity wound will improve following treatment as noted in patient's CIVIQ-20 scores | enrollment through 12 months of follow-up |