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

NCT02248077 | Withdrawn Phase 4

• 1 other identifier: CM-567
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Impaired Wound Healing

Outcome Measures

Primary Outcomes (1)

• Complete Ulcer Closure

  Proportion of patients with complete ulcer closure

  12 weeks

Study Arms (2)

AutoloGel

ACTIVE COMPARATOR

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

Usual and Customary Care (UCC)

OTHER

Standard of care

Other: Usual and Customary Care (UCC)

Interventions

AutoloGel DEVICE

AutoloGel

Usual and Customary Care (UCC) OTHER

Usual and Customary Care (UCC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytomedix: lead

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 25, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Last Updated: October 21, 2016

Record last verified: 2016-10