A Cohort Trial Comparing AutoloGel Therapy to Usual and Customary Care in Venous Leg Ulcers

NCT01817543 | Terminated DMC

• 1 other identifier: CM003
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, cohort-controlled trial in which venous leg ulcers (VLU)n will be treated using AutoloGel and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care (UCC)

Conditions

Venous Leg Ulcer

Keywords

venous leg ulcers; non healing wounds

Outcome Measures

Primary Outcomes (1)

• Time to wound closure

  Primary endpoint is time to wound healing after 12 weeks com pared with case matched controls receiving standard of care. 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).

  12 weeks

Secondary Outcomes (4)

• Proportion of wounds healed

  12 weeks

• Frequency of ulcer recurrence

  1 year

• Change in Quality of Life with Chronic Wounds (W-QOL) Score

  12 weeks

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

  12 weeks

Study Arms (1)

AutoloGel

EXPERIMENTAL

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

Device: AutoloGel

Interventions

AutoloGel DEVICE

Autologel is a platelet-rich plasma gel used in the treatment of non-healing wounds

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
• Proven venous disease
• The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located between and including the knee and the ankle
• For subjects with potentially multiple eligible VLUs, 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 2 cm2 and 200 cm2
• Demonstrated adequate compression 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
• Presence of another wound that is concurrently treated and might interfere with treatment of index wound by AutoloGel
• Ulcer not of VLU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, 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

Sponsors & Collaborators

• Cytomedix: lead

Study Sites (2)

Unknown Facility

Arcadia, California, 91007, United States

Location

HyperBarxs at Northside Forsyth

Cumming, Georgia, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; 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 25, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: October 21, 2016

Record last verified: 2016-10

Locations

US (2)