Status:
WITHDRAWN
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
Lead Sponsor:
Cytomedix
Conditions:
Impaired Wound Healing
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02248077
Start Date
October 1 2014
Last Update
October 21 2016
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