- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02248077
A Prospective, Randomized, Controlled, Multi-Center, Study Evaluating AutoloGel Therapy for Complete Closure of Wagner Grade 1-4 Diabetic Foot Ulcers, Venous Leg Ulcers and Stage II-IV Pressure Ulcers
October 19, 2016 updated by: Cytomedix
This study is designed to demonstrate the outcome of complete ulcer closure of patients with Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary Care (UCC).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
For DFU indication:
- Medicare beneficiary
- Males or females ≥ 18 years of age
- Type I or II diabetes requiring medical treatment as determined by the physician
- The single wound to be applied Study Treatment (Index Ulcer) is a Wagner 1-4 DFU (see Section 17.12 Appendix 12 for Wagner Classification) that is located on the dorsal, plantar, medial, or lateral aspect of the foot (including all toe surfaces and the heel)
- Patients have been treated with UCC at the center for 2 weeks prior to randomization with no greater than 20% reduction in wound area or volume and documented wound measurements are available
- For patients with multiple potential Index 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 patient should not be enrolled (screen failure)
- Demonstrated offloading regimen
- A wound age of ≥ 30 days at the Screening Visit
- Patient must be willing to comply with the protocol, which will be assessed by enrolling clinician.
- Patient must sign an Informed Consent Form prior to any study-related procedures.
For VLU indication:
- Medicare beneficiary
- Males or females ≥ 18 years of age
- Diagnosed venous disease
- Patients have been seen at the center/site for 2 weeks prior to randomization with no greater than 20% reduction in wound area or volume and documented wound measurements are available
- The non-healing wound is located between the knee and ankle and may include ankle
- For patients with multiple potential Index 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 patient should not be enrolled (screen failure)
- Demonstrated compression regimen
- A wound age of ≥ 30 days at the Screening visit
- Patient must be willing to comply with the protocol, which will be assessed by enrolling clinician
- Patient must sign an Informed Consent prior to any study-related procedures.
For PU indication:
- Medicare beneficiary
- Males or females ≥ 18 years of age
- Ulcer of pressure/shear etiology (Stage II, III, IV, see Section 17.13 Appendix 13 for stage definitions)
- Patients have been seen at the site for 2 weeks prior to randomization with no greater than 20% reduction in wound area or volume and documented wound measurements are available
- The single wound to be applied Study Treatment (Index Ulcer) that is located on the heel, ischium, sacrum, coccyx or trochanter
- For patients with multiple potential 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 patient should not be enrolled (screen failure)
- Demonstrated pressure relief regimen
- A wound age of ≥ 30 days at Screening visit
- Patient must be willing to comply with the Protocol, which will be assessed by enrolling clinician.
- Patient must sign an Informed Consent prior to any study-related procedures.
Exclusion Criteria:
- Patients 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 the treatment of the Index wound
- Malignancy in wound bed
- Active clinical wound infection.
- Patient has inadequate venous access for repeated blood draw required for AutoloGel processing
- Patients who are cognitively impaired and do not have a healthcare proxy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: AutoloGel
AutoloGel consists of platelet-rich plasma (PRP) gel produced from the patient's own peripheral blood and pharmaceutical additives including calcium chloride, thrombin and ascorbic acid.
The AutoloGel product is obtained by processing the patient's own blood using the AutoloGel System.
After the final AutoloGel formulation is produced it is used immediately for patient's specific ulcer care.
|
|
Other: Usual and Customary Care (UCC)
Standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Ulcer Closure
Time Frame: 12 weeks
|
Proportion of patients with complete ulcer closure
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
October 1, 2016
Study Registration Dates
First Submitted
September 22, 2014
First Submitted That Met QC Criteria
September 22, 2014
First Posted (Estimate)
September 25, 2014
Study Record Updates
Last Update Posted (Estimate)
October 21, 2016
Last Update Submitted That Met QC Criteria
October 19, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CM-567
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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