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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Impaired Wound Healing

Intervention / Treatment
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* Device: AutoloGel
* Other: Usual and Customary Care (UCC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AutoloGel<br>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. | Device: AutoloGel<br> <br> |
| Other: Usual and Customary Care (UCC)<br>Standard of care | Other: Usual and Customary Care (UCC)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Ulcer Closure | Proportion of patients with complete ulcer closure | 12 weeks |