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

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

Study Overview

• Status: Completed
• Conditions: Determine Effectiveness of Theraskin in the Treatment of DFU and VLU
• Intervention / Treatment: Other: Human Allograft (Theraskin)

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
• Enrollment (Actual): 188

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Fairfax, Virginia, United States, 22042
      • Inova Fairfax Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12-20 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Solsys Medical LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2003
• Primary Completion (ACTUAL): September 20, 2009
• Study Completion (ACTUAL): September 20, 2009

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (ACTUAL): June 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2019
• Last Update Submitted That Met QC Criteria: June 27, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SolubleS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No