Back to resultsAutoloGel Therapy to Usual and Customary Care in Pressure Ulcers
Primary Purpose
Pressure 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 Pressure Ulcer focused on measuring non healing wound, pressure ulcer
Eligibility Criteria
Inclusion Criteria:
- Medicare/Medicaid eligible
- ≥18 years of age
- Ulcer of pressure/shear etiology (Stage II, III, and IV, see Appendix 9 for stage definitions)
- The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located on the heel, ischium, sacrum, and trochanter
For subjects with potentially multiple eligible PUs, 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 3 cm2 and 200 cm2
- Demonstrated adequate offloading 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
- Stage I pressure ulcers
- Ulcers that are unstageable or of deep tissue morphology that have yet to become an open wound
- Presence of another wound that is concurrently treated and might interfere with treatment of index wound by AutoloGel
- Ulcer not of PU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, venous, 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.
10. Life expectancy of < 6 months.
Sites / Locations
- Singing River
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AutoloGel
Arm Description
Subjects will be treated with AutoloGel 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 patients will receive Autologel treatment
Outcomes
Primary Outcome Measures
Time to complete wound healing
Compare complete wound healing at 16 weeks for all pressure ulcers treated with AutoloGel plus standard of care with case-matched concurrent controls. 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
Ulcer recurrence
Frequency of ulcer recurrence (recurrence defined as any new ulcer that has appeared since the Index Ulcer healed)
Proportion of healed ulcers
Proportion of patients with completely healed pressure ulcers
W-QOL (Quality of Life with Chronic Wounds) score
Change in mean W-QOL (Quality of Life with Chronic Wounds) score between baseline and 16 weeks
Number of patients with adverse events as a measure of tolerability
Frequency and severity of adverse events during the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01819142
Brief Title
AutoloGel Therapy to Usual and Customary Care in Pressure Ulcers
Official Title
A Multi-Center, Prospective, Cohort Trial Comparing the Effectiveness of AutoloGel Therapy to Usual and Customary Care in Stage II-IV Pressure Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Protocol study design was re-worked in collaboration with CMS
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (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, case-matched cohort-controlled trial in which pressure ulcers will be treated using AutoloGel and standard care and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care.
Detailed Description
Pressure ulcers (PUs) are a common problem in all patient care settings, especially long-term acute care facilities and nursing homes. AutoloGel is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. The results of AutoloGel to date when used to treat PUs have been promising. The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort trial in which pressure ulcers will be treated using AutoloGel and standard of care to determine time to heal at 16 weeks. Comparison will be made with a case matched 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
Pressure Ulcer
Keywords
non healing wound, pressure ulcer
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 with AutoloGel 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 patients 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 (PRP) gel used in the treatment of non-healing chronic wounds. It will be administered twice weekly for 2 weeks then weekly.
Primary Outcome Measure Information:
Title
Time to complete wound healing
Description
Compare complete wound healing at 16 weeks for all pressure ulcers treated with AutoloGel plus standard of care with case-matched concurrent controls. 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
16 weeks
Secondary Outcome Measure Information:
Title
Ulcer recurrence
Description
Frequency of ulcer recurrence (recurrence defined as any new ulcer that has appeared since the Index Ulcer healed)
Time Frame
1 year
Title
Proportion of healed ulcers
Description
Proportion of patients with completely healed pressure ulcers
Time Frame
16 weeks
Title
W-QOL (Quality of Life with Chronic Wounds) score
Description
Change in mean W-QOL (Quality of Life with Chronic Wounds) score between baseline and 16 weeks
Time Frame
16 weeks
Title
Number of patients with adverse events as a measure of tolerability
Description
Frequency and severity of adverse events during the study
Time Frame
16 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
Ulcer of pressure/shear etiology (Stage II, III, and IV, see Appendix 9 for stage definitions)
The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located on the heel, ischium, sacrum, and trochanter
For subjects with potentially multiple eligible PUs, 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 3 cm2 and 200 cm2
Demonstrated adequate offloading 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
Stage I pressure ulcers
Ulcers that are unstageable or of deep tissue morphology that have yet to become an open wound
Presence of another wound that is concurrently treated and might interfere with treatment of index wound by AutoloGel
Ulcer not of PU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, venous, 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.
10. Life expectancy of < 6 months.
Facility Information:
Facility Name
Singing River
City
Pascagaula
State/Province
Mississippi
Country
United States
12. IPD Sharing Statement
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AutoloGel Therapy to Usual and Customary Care in Pressure Ulcers
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