Determine Effectiveness of Theraskin in the Treatment of DFU and VLUNCT03999281
Clinical Trial to Examine Effectiveness of a Human Allograft for Treatment of DFU and VLU
An observational study of Determine Effectiveness of Theraskin in the Treatment of DFU and VLU, run by Solsys Medical LLC at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Determine Effectiveness of Theraskin in the Treatment of DFU and VLU
- What is being tested?
- Human Allograft (Theraskin)
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2003to 20 Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Theraskin applied to lower extremity wound during the study period.
- Over 18 years of age.
- Males and Females.
- lower Extremity wound due to diabetic neuropathy or venous insufficiency.
- Documented palpable pedal pulse (dorsalis pedis and/or posterior tibialis arteries and/or palpable bypass graft), or ankle brachial index (ABI) in the range of > 0.8 to < 1.1 or Tcpo2 > 40 mm Hg from the foot at the time of the initial allograft applicaton
- In subjects with multiple wounds only the largest wound receiving the allograft was included and considered the target wound
Show all 10Show fewer
- Initial wound size >1 cm 2
- All wound locations within the lower extremity (defined as below the knee) and wound durations included
- Concomitant Negative pressure wound therapy was allowed as this could have been an anchoring technique for the allograft
- Concomitant antibiotics ( topical, oral, or intravenous) were allowed as it was not possible to determine whether administration of antibiotics was due to a true infection at the target wound site.
Who cannot join
- Wound etiologies other than diabetic neuropathy or nevous such as trauma, burns, sickle cell anemia, necrobiosis lipoidica , pyoderma gangrenosum.
- Wound not present for at least 30 days and showing lack of progression for at least 30 days prior to application of Theraskin.
- Other ulcer treatments besides study allograft during the study period ( study period definition: time of first allograft application up to 20 weeks) were not included in this study. These concomitant treatments specifically include hyperbaric oxygen treatments, venous ablation procedures, revascularization procedures including lower extremity bypass grafts or angioplasties or stents, application of additional growth factors, biologic products containing cells or other tissue-derived products, matrix components, or enzymatic debriders. Subjects were allowed to receive standard of care therapy with the study allograft, which included debridement, moist dressings or compression dressings depending on wound etiology, and off-weighting depending on wound location.
- Patients with revascularization procedures (defined as lower extremity bypass grafts, angioplasties, or stents) within 30 days of initial TheraSkin application were excluded
- Patients with successful surgical correction or intervention aimed at improving venous return in the target limb, such as venous ablation procedures, within 30 days of initial TheraSkin application were excluded
Trial locations and contacts
1 site in 1 country.
About this study
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
Retrospective clinical study of 188 patients to examine effectiveness of human cryopreserved allograft in the treatment of diabetic foot ulcers and venous leg ulcers
Read the 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
- Being tested
- Human Allograft (Theraskin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Allograft (Theraskin)Other
Biologically active cryopreserved human skin allograft (Theraskin) was used on both cohorts, both diabetic foot ulcer and venous leg ulcer.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Human Allograft (Theraskin) | |
| 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. Receives: Other: Human Allograft (Theraskin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary aim was to determine effectiveness of Theraskin together with standard of care
Theraskin used together with standard of care in healing DFU and VLU wounds
Measured: 12-20 weeks
Secondary outcomes (1)
Measure of effectiveness based on healing
Effectiveness was measured based on the proportion of complete wound closures at 12 and 20 weeks
Measured: 12-20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start20 Mar 2003
- Primary completion20 Sep 2009
- Study completion20 Sep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Determine Effectiveness of Theraskin in the Treatment of DFU and VLUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solsys Medical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999281
- Sponsor's protocol ID
- SolubleS
- Status last verified
- Jun 2019
- First submitted
- 24 Jun 2019
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03999281
- Acronym / sponsor ID
- SolubleS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Solsys Medical LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2003 (actual)
- Primary completion
- 20 Sep 2009 (actual)
- Study completion
- 20 Sep 2009 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic Foot Ulcers (DFU) | – | Other: Human Allograft (Theraskin)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 |
| Venous Leg Ulcer (VLU) | – | Other: Human Allograft (Theraskin)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- Theraskin applied to lower extremity wound during the study period.
- Over 18 years of age.
- Males and Females.
- lower Extremity wound due to diabetic neuropathy or venous insufficiency.
- Documented palpable pedal pulse (dorsalis pedis and/or posterior tibialis arteries and/or palpable bypass graft), or ankle brachial index (ABI) in the range of > 0.8 to < 1.1 or Tcpo2 > 40 mm Hg from the foot at the time of the initial allograft applicaton
Key exclusion criteria (5 listed)
- Wound etiologies other than diabetic neuropathy or nevous such as trauma, burns, sickle cell anemia, necrobiosis lipoidica , pyoderma gangrenosum.
- Wound not present for at least 30 days and showing lack of progression for at least 30 days prior to application of Theraskin.
- Other ulcer treatments besides study allograft during the study period ( study period definition: time of first allograft application up to 20 weeks) were not included in this study. These concomitant treatments specifically include hyperbaric oxygen treatments, venous ablation procedures, revascularization procedures including lower extremity bypass grafts or angioplasties or stents, application of additional growth factors, biologic products containing cells or other tissue-derived products, matrix components, or enzymatic debriders. Subjects were allowed to receive standard of care therapy with the study allograft, which included debridement, moist dressings or compression dressings depending on wound etiology, and off-weighting depending on wound location.
- Patients with revascularization procedures (defined as lower extremity bypass grafts, angioplasties, or stents) within 30 days of initial TheraSkin application were excluded
- Patients with successful surgical correction or intervention aimed at improving venous return in the target limb, such as venous ablation procedures, within 30 days of initial TheraSkin application were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Allograft (Theraskin)Biologically active cryopreserved human skin allograft (Theraskin) was used on both cohorts, both diabetic foot ulcer and venous leg ulcer. | Other | Diabetic Foot Ulcers (DFU), Venous Leg Ulcer (VLU) |
Primary outcome
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
1 secondary outcome
Measure of effectiveness based on healing
Time frame: 12-20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Determine Effectiveness of Theraskin in the Treatment of DFU and VLU, run by Solsys Medical LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary aim was to determine effectiveness of Theraskin together with standard of care (time frame: 12-20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.