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

NCT ID: NCT03999281

Last Updated: 2019-06-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 188 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-03-20
• Study Completion Date: 2009-09-20

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

Conditions

Determine Effectiveness of Theraskin in the Treatment of DFU and VLU

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Human Allograft (Theraskin)

Intervention Type: OTHER

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.

Human Allograft (Theraskin)

Intervention Type: OTHER

Biologically active cryopreserved human skin allograft (Theraskin) was used on both cohorts, both diabetic foot ulcer and venous leg ulcer.

Interventions

Human Allograft (Theraskin)

Biologically active cryopreserved human skin allograft (Theraskin) was used on both cohorts, both diabetic foot ulcer and venous leg ulcer.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Solsys Medical LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Inova Fairfax Hospital

Fairfax, Virginia, United States

Countries

United States

Other Identifiers

SolubleS

Identifier Type: -

Identifier Source: org_study_id