Clinical Trial to Examine Effectiveness of a Human Allograft for Treatment of DFU and VLU

Completed

• Conditions: Determine Effectiveness of Theraskin in the Treatment of DFU and VLU
• Interventions: Other: Human Allograft (Theraskin)

• Registration Number: NCT03999281
• Lead Sponsor: Solsys Medical LLC

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 Timeline

• Study Start: 2003-03-20
• Primary Completion: 2009-09-20
• Study Completion: 2009-09-20
• Status Verified: 2019-06
• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-26
• Last Update Submitted: 2019-06-27
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Venous Leg Ulcer (VLU)	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.
Diabetic Foot Ulcers (DFU)	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

Primary Outcome Measures

Name	Time	Method
Primary aim was to determine effectiveness of Theraskin together with standard of care	12-20 weeks	Theraskin used together with standard of care in healing DFU and VLU wounds

Secondary Outcome Measures

Name	Time	Method
Measure of effectiveness based on healing	12-20 weeks	Effectiveness was measured based on the proportion of complete wound closures at 12 and 20 weeks

Trial Locations

Locations (1)

Inova Fairfax Hospital; 🇺🇸 Fairfax, Virginia, United States