AutoloGel Therapy to Usual and Customary Care in Pressure Ulcers

Pressure Ulcer Clinical Trial

Official title:

A Multi-Center, Prospective, Cohort Trial Comparing the Effectiveness of AutoloGel Therapy to Usual and Customary Care in Stage II-IV Pressure Ulcers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01819142
• Other study ID #: CM004
• Status: Terminated
• Phase: N/A
• First received: March 21, 2013
• Last updated: October 19, 2016
• Start date: April 2013
• Est. completion date: January 2016

Study information

• Verified date: October 2016
• Source: Cytomedix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Singing River	Pascagaula	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Cytomedix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete wound healing	Compare complete wound healing at 16 weeks for all pressure ulcers treated with AutoloGel plus standard of care with case-matched concurrent controls. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart (FDA Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment, 2006).	16 weeks	No
Secondary	Ulcer recurrence	Frequency of ulcer recurrence (recurrence defined as any new ulcer that has appeared since the Index Ulcer healed)	1 year	No
Secondary	Proportion of healed ulcers	Proportion of patients with completely healed pressure ulcers	16 weeks	No
Secondary	W-QOL (Quality of Life with Chronic Wounds) score	Change in mean W-QOL (Quality of Life with Chronic Wounds) score between baseline and 16 weeks	16 weeks	No
Secondary	Number of patients with adverse events as a measure of tolerability	Frequency and severity of adverse events during the study	16 weeks	Yes