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出境医 / 临床实验 / Standard Compression Therapy With/Without Application of Skin Allograft (Theraskin) for Venous Leg Ulcer Treatment

Standard Compression Therapy With/Without Application of Skin Allograft (Theraskin) for Venous Leg Ulcer Treatment

Study Description
Brief Summary:
This study will compare the efficacy of using standard compression therapy for treatment of chronic venous leg ulcers vs. the standard compression therapy with the additional use of the application of a human allograft (Theraskin)

Condition or disease Intervention/treatment Phase
Chronic Venous Hypertension With Ulcer Procedure: Standard Multi-layered Compression dressing Procedure: Standard Multi-layered Compression dressing with a cryopreserved skin allograft (TheraSkin) Not Applicable

Detailed Description:
Given the propensity for venous leg ulcers to become refractory, long standing wounds, incorporating active biologic grafts into the standard compression therapy, may prove to accelerate wound healing. The two treatments to be compared in this study are both commonly used for the treatment of venous leg ulcers. Compression therapy has long been the standard for the treatment of venous leg ulcers. Standard Compression therapy consists of wound debridement, application of non adherent dressings and a three or four layer compression dressing. (PROFORE Multi-Layer Compression Bandage System) TheraSkin is a split thickness skin graft harvested within 24 hours postmortem, from an organ donor who has cleared the standard safety screenings. It is classified by the FDA as a donated tissue. Once harvested, the graft is sanitized according to FDA specifications, and cryopreserved, until it is delivered to the clinic for application to the foot ulcer. It is also a widely used treatment for diabetic foot ulcers. TREATMENT RATIONALE FOR THIS STUDY Chronic wounds of the lower extremities affect a substantial proportion of the population. Venous leg ulcers (VLUs) account for up to 90% of lower extremity wounds. The standard of care for treatment of VLU's in wound centers in the United States is Standard Compression therapy as described above, which may be combined with biologic graft materials applied to the wound bed. This study may assist physicians who treat VLU's by comparing efficacy and costs of two common treatments for VLU's in a prospective randomized clinical trial. The investigation will be a head-to-head study comparing widely used human skin allograft (Theraskin) along with Standard Compression Therapy vs Standard Compression Therapy alone. There is no randomized, prospective data comparing these two options in the treatment of VLU. Compression is superior to no compression and increases VLU healing rates. It is currently the mainstay of treatment for venous ulcers of the lower extremities. It is important to consider the underlying pathophysiology of these wounds. A history of deep vein thrombosis is regarded as a predisposing factor to venous insufficiency, and hence venous ulceration. Venous insufficiency is associated with increased hydrostatic pressure in the veins of the leg (Moffatt 207). External compression attempts to reverse this and aids venous return
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Clinical Trial Comparing Multi-layer Bandage Compression Therapy With and Without a Biologically Active Human Skin Allograft for the Treatment of Chronic Venous Leg Ulcers
Study Start Date : November 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Standard Compression
Standard multi-layer compression dressing with no graft or biologic material added
 Procedure: Standard Multi-layered Compression dressing
Compression therapy with a multi-layered compression dressing for the treatment of venous leg ulceration
Active Comparator: Standard Compression with application of human allograft
standard compression with application of a cryopreserved skin allograft (TheraSkin)
 Procedure: Standard Multi-layered Compression dressing with a cryopreserved skin allograft (TheraSkin)
Application of a cryopreserved skin allograft (TheraSkin) beneath compression therapy with a multi-layered compression dressing.
Outcome Measures
Primary Outcome Measures :
  1. Rate of wound healing, percentage of wounds that close, and change in wound size in subjects with venous leg ulcers treated with compression therapy with or without a cryopreserved skin allograft (TheraSkin) [ Time Frame: Enrollment and data analysis is anticipated to require approximately 3 years. ]
    Monitor changes in wound healing rate, percentage of wounds that close, and changes in wound size associated with two cohorts (multi-layered compression therapy vs. multi-layered compression therapy used in conjunction with a cryopreserved skin allograft.

  2. Determine the number and severity of adverse events associated with the two treatment cohorts -- standardized multi-layered compression therapy and the same therapy with a cryopreserved skin allograft added. [ Time Frame: Enrollment and data analysis is anticipated to require approximately 3 years. ]
    Measure the frequency and severity of adverse events associated with each treatment cohort.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Inclusion Criteria: Subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization.

  1. Adult patients with venous leg ulcer(s) >1 month.
  2. A signed and dated informed consent form.
  3. Subject is able to comply with instructions and scheduled visits, not confined to bed,.
  4. Ulcer surface area >2cm2 but not >10cm in any dimension. The total not to exceed 18cm2
  5. ABPI >.8, Doppler ultrasound (biphasic or triphasic waveforms) consistent with adequate blood flow to the affected extremity, as determined by the Investigator.
  6. There is a minimum 2 cm margin between the qualifying study ulcer and any other ulcers on the specified leg, post-debridement) Note: If the subject has more than one qualifying VLU, the ulcer designated as the study ulcer will be at the discretion of the Investigator..
  7. Casual smoker not exceeding one pack per week -

Exclusion Criteria:Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.

  1. Patients with ABPI <0.7.
  2. Clinical signs of infection requiring treatment. (Subjects with wound infection at the screening visit may be treated and re-screened for participation in the study after resolution of the infection).
  3. Taking systemic antibiotics, steroids or immunosuppressive drugs.
  4. History of poor compliance.
  5. Bedridden.
  6. Arterial or mixed etiology ulcers.
  7. Severe diabetic peripheral neuropathy.
  8. DVT in the last month.
  9. Participation in another clinical investigations in the month prior to recruitment.
  10. Poorly controlled hypertension.
  11. Coronary artery disease.
  12. Malignancy, respiratory or cardiac failure.
  13. Autoimmune disease.
  14. Liver (elevated enzymes)or kidney disease (elevated serum creatinine).
  15. Gangrene of the affected limb.
  16. Subject has suspected or confirmed signs/symptoms of gangrene or 5 wound infection on any part of the affected limb.
  17. Subject has a history of hypersensitivity to any of the material used in the compression dressing
  18. Subject has a history of hypersensitivity to any of the antibiotics or preservation agents listed in the TheraSkin Instructions for Use.
  19. Subject was previously treated under this clinical study protocol.
  20. Cytostatic therapy within the 12 months prior to randomization, dialysis, radiation therapy to the foot, vascular surgery, angioplasty or thrombolysis).
  21. Subject has osteomyelitis (If the Investigator suspects the presence of osteomyelitis, the diagnosis must be confirmed by plain film Xray.)
  22. Subject has a history of bone cancer or metastatic disease on the affected limb, radiation therapy to the foot or has had chemotherapy within the 12 months prior to randomization.
  23. Subject has been treated with wound dressings that include growth factors, engineered tissues, or skin substitutes (e.g., Regranex®, Dermagraft®, Apligraf®, TheraSkin®, GraftJacket®, OASIS®, Primatrix®, Matristem®, etc.) within 30 days of randomization.

  24. Subject has a history of or any of the following current illnesses or conditions (other than diabetes) that would compromise the safety of the subject, or the normal wound healing process:

    1. End-stage renal disease
    2. Immunosuppression
    3. Severe malnutrition
    4. Liver disease
    5. Aplastic anemia
    6. Scleroderma
    7. Acquired immune deficiency syndrome (AIDS) or HIV positive
    8. Connective tissue disorder
    9. Exacerbation of sickle cell anemia
  25. Subject is an employee or relative of any member of the Investigational site or the Sponsor.
  26. Subject is diabetic, HbA1c not to exceed 10% at time of enrollment.
  27. COPD -
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
Investigators
Layout table for investigator information
Principal Investigator: Philip Garrett, DPM Inova Hospital Wound Care Center
Tracking Information
First Submitted Date  ICMJE November 4, 2016
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date May 2, 2019
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Rate of wound healing, percentage of wounds that close, and change in wound size in subjects with venous leg ulcers treated with compression therapy with or without a cryopreserved skin allograft (TheraSkin) [ Time Frame: Enrollment and data analysis is anticipated to require approximately 3 years. ]
    Monitor changes in wound healing rate, percentage of wounds that close, and changes in wound size associated with two cohorts (multi-layered compression therapy vs. multi-layered compression therapy used in conjunction with a cryopreserved skin allograft.
  • Determine the number and severity of adverse events associated with the two treatment cohorts -- standardized multi-layered compression therapy and the same therapy with a cryopreserved skin allograft added. [ Time Frame: Enrollment and data analysis is anticipated to require approximately 3 years. ]
    Measure the frequency and severity of adverse events associated with each treatment cohort.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Standard Compression Therapy With/Without Application of Skin Allograft (Theraskin) for Venous Leg Ulcer Treatment
Official Title  ICMJE A Prospective Randomized Clinical Trial Comparing Multi-layer Bandage Compression Therapy With and Without a Biologically Active Human Skin Allograft for the Treatment of Chronic Venous Leg Ulcers
Brief Summary This study will compare the efficacy of using standard compression therapy for treatment of chronic venous leg ulcers vs. the standard compression therapy with the additional use of the application of a human allograft (Theraskin)
Detailed Description Given the propensity for venous leg ulcers to become refractory, long standing wounds, incorporating active biologic grafts into the standard compression therapy, may prove to accelerate wound healing. The two treatments to be compared in this study are both commonly used for the treatment of venous leg ulcers. Compression therapy has long been the standard for the treatment of venous leg ulcers. Standard Compression therapy consists of wound debridement, application of non adherent dressings and a three or four layer compression dressing. (PROFORE Multi-Layer Compression Bandage System) TheraSkin is a split thickness skin graft harvested within 24 hours postmortem, from an organ donor who has cleared the standard safety screenings. It is classified by the FDA as a donated tissue. Once harvested, the graft is sanitized according to FDA specifications, and cryopreserved, until it is delivered to the clinic for application to the foot ulcer. It is also a widely used treatment for diabetic foot ulcers. TREATMENT RATIONALE FOR THIS STUDY Chronic wounds of the lower extremities affect a substantial proportion of the population. Venous leg ulcers (VLUs) account for up to 90% of lower extremity wounds. The standard of care for treatment of VLU's in wound centers in the United States is Standard Compression therapy as described above, which may be combined with biologic graft materials applied to the wound bed. This study may assist physicians who treat VLU's by comparing efficacy and costs of two common treatments for VLU's in a prospective randomized clinical trial. The investigation will be a head-to-head study comparing widely used human skin allograft (Theraskin) along with Standard Compression Therapy vs Standard Compression Therapy alone. There is no randomized, prospective data comparing these two options in the treatment of VLU. Compression is superior to no compression and increases VLU healing rates. It is currently the mainstay of treatment for venous ulcers of the lower extremities. It is important to consider the underlying pathophysiology of these wounds. A history of deep vein thrombosis is regarded as a predisposing factor to venous insufficiency, and hence venous ulceration. Venous insufficiency is associated with increased hydrostatic pressure in the veins of the leg (Moffatt 207). External compression attempts to reverse this and aids venous return
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Venous Hypertension With Ulcer
Intervention  ICMJE
  • Procedure: Standard Multi-layered Compression dressing
    Compression therapy with a multi-layered compression dressing for the treatment of venous leg ulceration
  • Procedure: Standard Multi-layered Compression dressing with a cryopreserved skin allograft (TheraSkin)
    Application of a cryopreserved skin allograft (TheraSkin) beneath compression therapy with a multi-layered compression dressing.
Study Arms  ICMJE
  • Active Comparator: Standard Compression
    Standard multi-layer compression dressing with no graft or biologic material added
    Intervention: Procedure: Standard Multi-layered Compression dressing
  • Active Comparator: Standard Compression with application of human allograft
    standard compression with application of a cryopreserved skin allograft (TheraSkin)
    Intervention: Procedure: Standard Multi-layered Compression dressing with a cryopreserved skin 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  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 30, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:Inclusion Criteria: Subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization.

  1. Adult patients with venous leg ulcer(s) >1 month.
  2. A signed and dated informed consent form.
  3. Subject is able to comply with instructions and scheduled visits, not confined to bed,.
  4. Ulcer surface area >2cm2 but not >10cm in any dimension. The total not to exceed 18cm2
  5. ABPI >.8, Doppler ultrasound (biphasic or triphasic waveforms) consistent with adequate blood flow to the affected extremity, as determined by the Investigator.
  6. There is a minimum 2 cm margin between the qualifying study ulcer and any other ulcers on the specified leg, post-debridement) Note: If the subject has more than one qualifying VLU, the ulcer designated as the study ulcer will be at the discretion of the Investigator..
  7. Casual smoker not exceeding one pack per week -

Exclusion Criteria:Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.

  1. Patients with ABPI <0.7.
  2. Clinical signs of infection requiring treatment. (Subjects with wound infection at the screening visit may be treated and re-screened for participation in the study after resolution of the infection).
  3. Taking systemic antibiotics, steroids or immunosuppressive drugs.
  4. History of poor compliance.
  5. Bedridden.
  6. Arterial or mixed etiology ulcers.
  7. Severe diabetic peripheral neuropathy.
  8. DVT in the last month.
  9. Participation in another clinical investigations in the month prior to recruitment.
  10. Poorly controlled hypertension.
  11. Coronary artery disease.
  12. Malignancy, respiratory or cardiac failure.
  13. Autoimmune disease.
  14. Liver (elevated enzymes)or kidney disease (elevated serum creatinine).
  15. Gangrene of the affected limb.
  16. Subject has suspected or confirmed signs/symptoms of gangrene or 5 wound infection on any part of the affected limb.
  17. Subject has a history of hypersensitivity to any of the material used in the compression dressing
  18. Subject has a history of hypersensitivity to any of the antibiotics or preservation agents listed in the TheraSkin Instructions for Use.
  19. Subject was previously treated under this clinical study protocol.
  20. Cytostatic therapy within the 12 months prior to randomization, dialysis, radiation therapy to the foot, vascular surgery, angioplasty or thrombolysis).
  21. Subject has osteomyelitis (If the Investigator suspects the presence of osteomyelitis, the diagnosis must be confirmed by plain film Xray.)
  22. Subject has a history of bone cancer or metastatic disease on the affected limb, radiation therapy to the foot or has had chemotherapy within the 12 months prior to randomization.
  23. Subject has been treated with wound dressings that include growth factors, engineered tissues, or skin substitutes (e.g., Regranex®, Dermagraft®, Apligraf®, TheraSkin®, GraftJacket®, OASIS®, Primatrix®, Matristem®, etc.) within 30 days of randomization.

  24. Subject has a history of or any of the following current illnesses or conditions (other than diabetes) that would compromise the safety of the subject, or the normal wound healing process:

    1. End-stage renal disease
    2. Immunosuppression
    3. Severe malnutrition
    4. Liver disease
    5. Aplastic anemia
    6. Scleroderma
    7. Acquired immune deficiency syndrome (AIDS) or HIV positive
    8. Connective tissue disorder
    9. Exacerbation of sickle cell anemia
  25. Subject is an employee or relative of any member of the Investigational site or the Sponsor.
  26. Subject is diabetic, HbA1c not to exceed 10% at time of enrollment.
  27. COPD -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03935386
Other Study ID Numbers  ICMJE Soluble Inova
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Solsys Medical LLC
Study Sponsor  ICMJE Solsys Medical LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip Garrett, DPM Inova Hospital Wound Care Center
PRS Account Solsys Medical LLC
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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