Effectiveness of Aurix Therapy in Venous Leg Ulcers

Venous Leg Ulcers Clinical Trial

Official title:

A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in Venous Leg Ulcers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02940587
• Other study ID #: CM003 Gold
• Status: Withdrawn
• Phase: Phase 4
• First received: October 19, 2016
• Last updated: October 19, 2016
• Start date: February 2015
• Est. completion date: February 2018

Study information

• Verified date: January 2015
• Source: Cytomedix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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, randomized trial in which venous leg ulcers (VLU)n will be treated using Aurix and compared to patients receiving undefined Usual and Customary Care (UCC)

Description:

Recurrence of ulcers in the leg is common; two-thirds of patients are likely to experience recurring ulcers after the first ulcer. While treatment of the underlying venous disease, depending on the mode of treatment, can lower the recurrence rate in many patients, it does not affect recurrence. Aurix is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. The aim of this trial is to demonstrate the effectiveness, measured as complete wound healing, in a prospective, randomized trial in which venous leg ulcers will be treated using Aurix and standard of care and compared 1:1 to patients receiving undefined Usual and Customary Care (UCC).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Medicare eligible

2. =18 years of age

3. Proven venous disease

4. 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

5. For subjects with potentially multiple eligible VLUs, the largest ulcer will be selected as Index Ulcer for study. 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 2 cm2 and 200 cm2

7. Subject has received UCC care for = 2 weeks at treating wound clinic

8. Demonstrated adequate compression regimen

9. Duration = 1 month at first visit

10. 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 Aurix 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 index wound by Aurix

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

4. Patients on chemotherapeutic agents or any malignancy in the wound area

5. Subjects who are cognitively impaired

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 Aurix Administration.

Study Design

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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcers

Intervention

Device:
• Aurix
Aurix is a platelet-rich plasma gel used in the treatment of non-healing wounds. It will be administered twice weekly for 2 weeks then weekly.

Locations

Country	Name	City	State
United States	St. Luke's Intermountain Research	Boise	Idaho

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 Heal	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	No
Secondary	Proportion of wounds healed	Comparison of proportion of wounds healed over 12 weeks	12 weeks	Yes
Secondary	Change in Quality of Life with Chronic Wounds (W-QOL) Score	Change in mean Quality of Life with Chronic Wounds (W-QOL) score between baseline and at 12 weeks	12 weeks	No