4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Clinical Trial to Examine Effectiveness of a Human Allograft for Treatment of DFU and VLU

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

Study Description
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

Condition or disease Intervention/treatment
Determine Effectiveness of Theraskin in the Treatment of DFU and VLU 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 Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 188 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : March 20, 2003
Actual Primary Completion Date : September 20, 2009
Actual Study Completion Date : September 20, 2009
Arms 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.

Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Measure of effectiveness based on healing [ Time Frame: 12-20 weeks ]
    Effectiveness was measured based on the proportion of complete wound closures at 12 and 20 weeks


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

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
Contacts and Locations

Locations
Layout table for location information
United States, Virginia
Inova Fairfax Hospital
Fairfax, Virginia, United States, 22042
Sponsors and Collaborators
Solsys Medical LLC
Tracking Information
First Submitted Date June 24, 2019
First Posted Date June 26, 2019
Last Update Posted Date June 28, 2019
Actual Study Start Date March 20, 2003
Actual Primary Completion Date September 20, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 24, 2019)
Measure of effectiveness based on healing [ Time Frame: 12-20 weeks ]
Effectiveness was measured based on the proportion of complete wound closures at 12 and 20 weeks
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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

Condition Determine Effectiveness of Theraskin in the Treatment of DFU and VLU
Intervention Other: Human Allograft (Theraskin)
Biologically active cryopreserved human skin allograft (Theraskin) was used on both cohorts, both diabetic foot ulcer and venous leg ulcer.
Study Groups/Cohorts
  • 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
    Intervention: 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.
    Intervention: Other: Human Allograft (Theraskin)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 24, 2019)
188
Original Actual Enrollment Same as current
Actual Study Completion Date September 20, 2009
Actual Primary Completion Date September 20, 2009   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03999281
Other Study ID Numbers SolubleS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Solsys Medical LLC
Study Sponsor Solsys Medical LLC
Collaborators Not Provided
Investigators Not Provided
PRS Account Solsys Medical LLC
Verification Date June 2019