Back to resultsEffectiveness of AutoloGel Therapy in Diabetic Foot Ulcers
Primary Purpose
Diabetic Foot Ulcers
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 Diabetic Foot Ulcers focused on measuring non healing wound
Eligibility Criteria
Inclusion Criteria:
- Medicare/Medicaid eligible
- ≥18 years of age
- Type I or II diabetes requiring medical treatment as determined by the physician
- The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) is a Wagner 1-5 DFU (see Appendix 9 for Wagner Classification) that is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces)
- For subjects with potentially multiple eligible DFUs, 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 0.5 cm2 and 50 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
- Presence of another wound that is concurrently treated and might interfere with treatment of the index wound by AutoloGel (malignancy in nearby wound)
- Ulcer not of DFU pathophysiology (e.g., venous, 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 heal
The primary objective of the trial is to determine the time to heal diabetic foot ulcers treated with Autologel and Standard of Care at 12 weeks DFUs. Comparison will be made with a concurrent cohort of case matched subjects
Secondary Outcome Measures
Ulcer recurrence
Frequency of ulcer recurrence defined as any new ulcer appearing after the index ulcer healed
Incidence of amputations
Frequency of lower extremity amputations; major/minor amputations will be tabulated but not tested.
Proportion of completely healed ulcers
Proportion of patients with completely healed diabetic foot 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 12 weeks
Number of patients with adverse events as a measure of tolerability
Frequency and severity of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01816633
Brief Title
Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers
Official Title
A Multi-Center, Prospective, Cohort Trial Comparing the Effectiveness of AutoloGel Therapy to Usual and Customary Care in All Wagner Grades of Diabetic Foot 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, case-matched cohort trial in which diabetic foot ulcers (DFU) will be treated using AutoloGel and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care (UCC) as provided in up to 30 U.S. Wound Registry Research Network (USWRRN) centers.
Detailed Description
AutoloGel is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. Prospective observational studies of the effectiveness of AutoloGel have demonstrated promising results in regard to the healing of DFUs, including severe Wagner grade 3 and 4 ulcers. 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 diabetic foot ulcers will be treated using AutoloGel to determine the time to heal at 12 weeks. Comparison will be made with a case-matched concurrent cohort of patients receiving undefined Usual and Customary Care (UCC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
Keywords
non healing wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (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
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 heal
Description
The primary objective of the trial is to determine the time to heal diabetic foot ulcers treated with Autologel and Standard of Care at 12 weeks DFUs. Comparison will be made with a concurrent cohort of case matched subjects
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Ulcer recurrence
Description
Frequency of ulcer recurrence defined as any new ulcer appearing after the index ulcer healed
Time Frame
1 year
Title
Incidence of amputations
Description
Frequency of lower extremity amputations; major/minor amputations will be tabulated but not tested.
Time Frame
1 year
Title
Proportion of completely healed ulcers
Description
Proportion of patients with completely healed diabetic foot ulcers
Time Frame
12 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 12 weeks
Time Frame
12 weeks
Title
Number of patients with adverse events as a measure of tolerability
Description
Frequency and severity of 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
Type I or II diabetes requiring medical treatment as determined by the physician
The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) is a Wagner 1-5 DFU (see Appendix 9 for Wagner Classification) that is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces)
For subjects with potentially multiple eligible DFUs, 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 0.5 cm2 and 50 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
Presence of another wound that is concurrently treated and might interfere with treatment of the index wound by AutoloGel (malignancy in nearby wound)
Ulcer not of DFU pathophysiology (e.g., venous, 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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Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers
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