Clinical trial NCT03999281: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Determine Effectiveness of Theraskin in the Treatment of DFU and VLU
Lead sponsor: Solsys Medical LLC
Sponsor class: INDUSTRY
First posted: 2019-06-26
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

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

Eligibility criteria: Inclusion Criteria:

1. Theraskin applied to lower extremity wound during the study period.
2. Over 18 years of age.
3. Males and Females.
4. lower Extremity wound due to diabetic neuropathy or venous insufficiency.
5. 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
6. In subjects with multiple wounds only the largest wound receiving the allograft was included and considered the target wound
7. Initial wound size \>1 cm 2
8. All wound locations within the lower extremity (defined as below the knee) and wound durations included
9. Concomitant Negative pressure wound therapy was allowed as this could have been an anchoring technique for the allograft
10. 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.

Exclusion Criteria:

1. Wound etiologies other than diabetic neuropathy or nevous such as trauma, burns, sickle cell anemia, necrobiosis lipoidica , pyoderma gangrenosum.
2. Wound not present for at least 30 days and showing lack of progression for at least 30 days prior to application of Theraskin.
3. 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.
4. Patients with revascularization procedures (defined as lower extremity bypass grafts, angioplasties, or stents) within 30 days of initial TheraSkin application were excluded
5. 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

Primary outcomes:
measure: Primary aim was to determine effectiveness of Theraskin together with standard of care
timeFrame: 12-20 weeks
Secondary outcomes:
measure: Measure of effectiveness based on healing
timeFrame: 12-20 weeks
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
References: