Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers

NCT ID: NCT01816633

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-01-31

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).

Conditions

Diabetic Foot Ulcers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AutoloGel

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.

Group Type: EXPERIMENTAL

AutoloGel

Intervention Type: DEVICE

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

Interventions

AutoloGel

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Medicare/Medicaid eligible

2. ≥18 years of age

3. Type I or II diabetes requiring medical treatment as determined by the physician

4. 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)

5. 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)

6. Debrided ulcer size between 0.5 cm2 and 50 cm2

7. Demonstrated adequate offloading regimen

8. Duration ≥ 1 month at first visit

9. Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.

Exclusion Criteria

1. Subjects known to be sensitive to AutoloGel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin

2. Presence of another wound that is concurrently treated and might interfere with treatment of the index wound by AutoloGel (malignancy in nearby wound)

3. Ulcer not of DFU pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)

4. Any malignancy other than non-melanoma skin cancer

5. Subjects who are cognitively impaired and do not have a healthcare proxy

6. Serum albumin of less than 2.5 g/dL

7. Plasma Platelet count of less than 100 x 109/L

8. Hemoglobin of less than 10.5 g/dL

9. Subject has inadequate venous access for repeated blood draw required for AutoloGel Administration.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cytomedix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Arcadia, California, United States

HyperBarxs at Northside Forsyth

Cumming, Georgia, United States

Countries

United States

Other Identifiers

CM002

Identifier Type: -

Identifier Source: org_study_id