AutoloGel Therapy to Usual and Customary Care in Pressure Ulcers

NCT ID: NCT01819142

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-01-31

Brief Summary

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort-controlled trial in which pressure ulcers will be treated using AutoloGel and standard care and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care.

Detailed Description

Pressure ulcers (PUs) are a common problem in all patient care settings, especially long-term acute care facilities and nursing homes. AutoloGel is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. The results of AutoloGel to date when used to treat PUs have been promising. 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 pressure ulcers will be treated using AutoloGel and standard of care to determine time to heal at 16 weeks. Comparison will be made with a case matched concurrent cohort of patients receiving undefined Usual and Customary Care.

Conditions

Pressure Ulcer

Study Design

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

Study Groups

AutoloGel

Subjects will be treated with AutoloGel 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 patients 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

Other Intervention Names

Autologel System

Eligibility Criteria

Inclusion Criteria

1. Medicare/Medicaid eligible

2. ≥18 years of age

3. Ulcer of pressure/shear etiology (Stage II, III, and IV, see Appendix 9 for stage definitions)

4. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located on the heel, ischium, sacrum, and trochanter

5. For subjects with potentially multiple eligible 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 subject should not be enrolled (screen failure)

6. Debrided ulcer size between 3 cm2 and 200 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. Stage I pressure ulcers

3. Ulcers that are unstageable or of deep tissue morphology that have yet to become an open wound

4. Presence of another wound that is concurrently treated and might interfere with treatment of index wound by AutoloGel

5. Ulcer not of PU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, venous, or arterial etiology)

6. Any malignancy other than non-melanoma skin cancer

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

8. Serum albumin of less than 2.5 g/dL

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

10. Hemoglobin of less than 10.5 g/dL

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

10. Life expectancy of < 6 months.

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

Sponsors

Cytomedix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Singing River

Pascagaula, Mississippi, United States

Countries

United States

Other Identifiers

CM004

Identifier Type: -

Identifier Source: org_study_id