AutoloGel Therapy to Usual and Customary Care in Pressure Ulcers

NCT01819142 | Terminated DMC

• 1 other identifier: CM004
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer

Keywords

non healing wound; pressure ulcer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Ulcer recurrence

  1 year

• Proportion of healed ulcers

  16 weeks

• W-QOL (Quality of Life with Chronic Wounds) score

  16 weeks

• Number of patients with adverse events as a measure of tolerability

  16 weeks

Study Arms (1)

AutoloGel

EXPERIMENTAL

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

Device: AutoloGel

Interventions

AutoloGel 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.

Also known as: Autologel System

AutoloGel

Eligibility Criteria

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

You may qualify if:

• Medicare/Medicaid eligible
• ≥18 years of age
• Ulcer of pressure/shear etiology (Stage II, III, and IV, see Appendix 9 for stage definitions)
• 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
• 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)
• Debrided ulcer size between 3 cm2 and 200 cm2
• Demonstrated adequate offloading regimen
• Duration ≥ 1 month at first visit
• Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.

You may not qualify if:

• Subjects known to be sensitive to AutoloGel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
• Stage I pressure ulcers
• Ulcers that are unstageable or of deep tissue morphology that have yet to become an open wound
• Presence of another wound that is concurrently treated and might interfere with treatment of index wound by AutoloGel
• Ulcer not of PU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, venous, or arterial etiology)
• Any malignancy other than non-melanoma skin cancer
• Subjects who are cognitively impaired and do not have a healthcare proxy
• Serum albumin of less than 2.5 g/dL
• Plasma Platelet count of less than 100 x 109/L
• Hemoglobin of less than 10.5 g/dL
• Subject has inadequate venous access for repeated blood draw required for AutoloGel Administration.
• \. Life expectancy of \< 6 months.

Sponsors & Collaborators

• Cytomedix: lead

Study Sites (1)

Singing River

Pascagaula, Mississippi, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 27, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 21, 2016

Record last verified: 2016-10

Locations

US (1)