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

Venous Leg Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01817543
• Other study ID #: CM003
• Status: Terminated
• Phase: N/A
• First received: March 21, 2013
• Last updated: October 19, 2016
• Start date: October 2013
• Est. completion date: January 2015

Study information

• Verified date: October 2016
• 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, 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)

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. AutoloGel 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, open-label trial in which venous leg ulcers will be treated using AutoloGel and standard of care and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• 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. 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. 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. Demonstrated adequate compression 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. Presence of another wound that is concurrently treated and might interfere with treatment of index wound by AutoloGel

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

4. Any malignancy other than non-melanoma skin cancer

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

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 AutoloGel Administration

Study Design

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	HyperBarxs at Northside Forsyth	Cumming	Georgia

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 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	No
Secondary	Proportion of wounds healed	Comparison of proportion of wounds healed over 12 weeks	12 weeks	No
Secondary	Frequency of ulcer recurrence	Frequency of ulcer recurrence over a 1 year period post treatment; recurrence is defined as any new ulcer appearing on the leg after the index ulcer has healed.	1 year	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
Secondary	Number of patients with adverse events as a measure of tolerability	Frequency and severity of treatment emergent adverse events	12 weeks	Yes