Back to resultsA Cohort Trial Comparing AutoloGel Therapy to Usual and Customary Care in Venous Leg Ulcers
Primary Purpose
Venous Leg Ulcer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AutoloGel
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcer focused on measuring venous leg ulcers, non healing wounds
Eligibility Criteria
Inclusion Criteria:
- Medicare/Medicaid eligible
- ≥18 years of age
- Proven venous disease
- The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located between and including the knee and the ankle
- For subjects with potentially multiple eligible VLUs, the largest ulcer will be selected. There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)
- Debrided ulcer size between 2 cm2 and 200 cm2
- Demonstrated adequate compression regimen
- Duration ≥ 1 month at first visit
- Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.
Exclusion Criteria:
- Subjects known to be sensitive to AutoloGel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
- Presence of another wound that is concurrently treated and might interfere with treatment of index wound by AutoloGel
- Ulcer not of VLU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
- Any malignancy other than non-melanoma skin cancer
- Subjects who are cognitively impaired and do not have a healthcare proxy
- Serum albumin of less than 2.5 g/dL
- Plasma Platelet count of less than 100 x 109/L
- Hemoglobin of less than 10.5 g/dL
- Subject has inadequate venous access for repeated blood draw required for AutoloGel Administration
Sites / Locations
- HyperBarxs at Northside Forsyth
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AutoloGel
Arm Description
Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week thereafter while under active treatment, but actual frequency of treatment will be determined by the treating physician. All subjects will receive Autologel treatment
Outcomes
Primary Outcome Measures
Time to wound closure
Primary endpoint is time to wound healing after 12 weeks com pared with case matched controls receiving standard of care. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart (FDA Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment, 2006).
Secondary Outcome Measures
Proportion of wounds healed
Comparison of proportion of wounds healed over 12 weeks
Frequency of ulcer recurrence
Frequency of ulcer recurrence over a 1 year period post treatment; recurrence is defined as any new ulcer appearing on the leg after the index ulcer has healed.
Change in Quality of Life with Chronic Wounds (W-QOL) Score
Change in mean Quality of Life with Chronic Wounds (W-QOL) score between baseline and at 12 weeks
Number of patients with adverse events as a measure of tolerability
Frequency and severity of treatment emergent adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01817543
Brief Title
A Cohort Trial Comparing AutoloGel Therapy to Usual and Customary Care in Venous Leg Ulcers
Official Title
A Multi-Center, Prospective, Cohort Trial Comparing the Effectiveness of AutoloGel Therapy to Usual and Customary Care in Venous Leg Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Protocol study design was re-done in collaboration with CMS
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytomedix
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, cohort-controlled trial in which venous leg ulcers (VLU)n will be treated using AutoloGel and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care (UCC)
Detailed Description
Recurrence of ulcers in the leg is common; two-thirds of patients are likely to experience recurring ulcers after the first ulcer. While treatment of the underlying venous disease, depending on the mode of treatment, can lower the recurrence rate in many patients, it does not affect recurrence. AutoloGel is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. The aim of this trial is to demonstrate the effectiveness, measured as complete wound healing, in a prospective, open-label trial in which venous leg ulcers will be treated using AutoloGel and standard of care and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer
Keywords
venous leg ulcers, non healing wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AutoloGel
Arm Type
Experimental
Arm Description
Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week thereafter while under active treatment, but actual frequency of treatment will be determined by the treating physician. All subjects will receive Autologel treatment
Intervention Type
Device
Intervention Name(s)
AutoloGel
Other Intervention Name(s)
AutoloGel System
Intervention Description
Autologel is a platelet-rich plasma gel used in the treatment of non-healing wounds
Primary Outcome Measure Information:
Title
Time to wound closure
Description
Primary endpoint is time to wound healing after 12 weeks com pared with case matched controls receiving standard of care. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart (FDA Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment, 2006).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Proportion of wounds healed
Description
Comparison of proportion of wounds healed over 12 weeks
Time Frame
12 weeks
Title
Frequency of ulcer recurrence
Description
Frequency of ulcer recurrence over a 1 year period post treatment; recurrence is defined as any new ulcer appearing on the leg after the index ulcer has healed.
Time Frame
1 year
Title
Change in Quality of Life with Chronic Wounds (W-QOL) Score
Description
Change in mean Quality of Life with Chronic Wounds (W-QOL) score between baseline and at 12 weeks
Time Frame
12 weeks
Title
Number of patients with adverse events as a measure of tolerability
Description
Frequency and severity of treatment emergent adverse events
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Medicare/Medicaid eligible
≥18 years of age
Proven venous disease
The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located between and including the knee and the ankle
For subjects with potentially multiple eligible VLUs, the largest ulcer will be selected. There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)
Debrided ulcer size between 2 cm2 and 200 cm2
Demonstrated adequate compression regimen
Duration ≥ 1 month at first visit
Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.
Exclusion Criteria:
Subjects known to be sensitive to AutoloGel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
Presence of another wound that is concurrently treated and might interfere with treatment of index wound by AutoloGel
Ulcer not of VLU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
Any malignancy other than non-melanoma skin cancer
Subjects who are cognitively impaired and do not have a healthcare proxy
Serum albumin of less than 2.5 g/dL
Plasma Platelet count of less than 100 x 109/L
Hemoglobin of less than 10.5 g/dL
Subject has inadequate venous access for repeated blood draw required for AutoloGel Administration
Facility Information:
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
HyperBarxs at Northside Forsyth
City
Cumming
State/Province
Georgia
Country
United States
12. IPD Sharing Statement
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A Cohort Trial Comparing AutoloGel Therapy to Usual and Customary Care in Venous Leg Ulcers
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