| Condition or disease | Intervention/treatment |
|---|---|
| Determine Effectiveness of Theraskin in the Treatment of DFU and VLU | Other: Human Allograft (Theraskin) |
| Study Type : | Observational |
| Actual Enrollment : | 188 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Retrospective |
| Official Title: | Retrospective Clinical Trial Study of 188 Consecutive Patients to Examine the Effectiveness of a Biological Active Cryopreserved Human Skin Allograft on the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers |
| Actual Study Start Date : | March 20, 2003 |
| Actual Primary Completion Date : | September 20, 2009 |
| Actual Study Completion Date : | September 20, 2009 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Diabetic Foot Ulcers (DFU)
Study began with 214 consecutive patient; After excluding patients who did not meet the study criteria, the final eligible cohort consisted of 188 subjects, with 54 with diabetic foot ulcers
|
Other: Human Allograft (Theraskin)
Biologically active cryopreserved human skin allograft (Theraskin) was used on both cohorts, both diabetic foot ulcer and venous leg ulcer.
|
|
Venous Leg Ulcer (VLU)
Study began with 214 consecutive patient; After excluding patients who did not meet the study criteria, the final eligible cohort consisted of 188 subjects, with 134 venous leg ulcers.
|
Other: Human Allograft (Theraskin)
Biologically active cryopreserved human skin allograft (Theraskin) was used on both cohorts, both diabetic foot ulcer and venous leg ulcer.
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Population included ages 18- any age, males 50.5 % and females 49.5%, There was more males in the diabetic subset and more females in the venous subset.
Percentage by Race: White: 72.3, Black: 17.6, Hispanic: 4.8 and unknown: 5.3
Inclusion Criteria:
Exclusion Criteria:
| United States, Virginia | |
| Inova Fairfax Hospital | |
| Fairfax, Virginia, United States, 22042 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 24, 2019 | ||||
| First Posted Date | June 26, 2019 | ||||
| Last Update Posted Date | June 28, 2019 | ||||
| Actual Study Start Date | March 20, 2003 | ||||
| Actual Primary Completion Date | September 20, 2009 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Primary aim was to determine effectiveness of Theraskin together with standard of care [ Time Frame: 12-20 weeks ] Theraskin used together with standard of care in healing DFU and VLU wounds
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
Measure of effectiveness based on healing [ Time Frame: 12-20 weeks ] Effectiveness was measured based on the proportion of complete wound closures at 12 and 20 weeks
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Clinical Trial to Examine Effectiveness of a Human Allograft for Treatment of DFU and VLU | ||||
| Official Title | Retrospective Clinical Trial Study of 188 Consecutive Patients to Examine the Effectiveness of a Biological Active Cryopreserved Human Skin Allograft on the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers | ||||
| Brief Summary | Retrospective clinical study of 188 patients to examine effectiveness of human cryopreserved allograft in the treatment of diabetic foot ulcers and venous leg ulcers | ||||
| Detailed Description | Retrospective Observational study of 188 consecutive patients to examine the efficacy of biologically active cryopreserved human skin allograft (Theraskin) on the treatment of diabetic foot ulcers and venous leg ulcers | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population |
Population included ages 18- any age, males 50.5 % and females 49.5%, There was more males in the diabetic subset and more females in the venous subset. Percentage by Race: White: 72.3, Black: 17.6, Hispanic: 4.8 and unknown: 5.3 |
||||
| Condition | Determine Effectiveness of Theraskin in the Treatment of DFU and VLU | ||||
| Intervention | Other: Human Allograft (Theraskin)
Biologically active cryopreserved human skin allograft (Theraskin) was used on both cohorts, both diabetic foot ulcer and venous leg ulcer.
|
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
188 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | September 20, 2009 | ||||
| Actual Primary Completion Date | September 20, 2009 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03999281 | ||||
| Other Study ID Numbers | SolubleS | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Solsys Medical LLC | ||||
| Study Sponsor | Solsys Medical LLC | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Solsys Medical LLC | ||||
| Verification Date | June 2019 | ||||