Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers

NCT01816633 | Terminated DMC

• 1 other identifier: CM002
• Study Type: interventional
• Target: 3
• 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, case-matched cohort trial in which diabetic foot ulcers (DFU) will be treated using AutoloGel and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care (UCC) as provided in up to 30 U.S. Wound Registry Research Network (USWRRN) centers.

Conditions

Diabetic Foot Ulcers

Keywords

non healing wound

Outcome Measures

Primary Outcomes (1)

• Time to heal

  The primary objective of the trial is to determine the time to heal diabetic foot ulcers treated with Autologel and Standard of Care at 12 weeks DFUs. Comparison will be made with a concurrent cohort of case matched subjects

  12 weeks

Secondary Outcomes (5)

• Ulcer recurrence

  1 year

• Incidence of amputations

  1 year

• Proportion of completely healed ulcers

  12 weeks

• W-QOL (Quality of life with Chronic Wounds) 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 (PRP) gel used in the treatment of non-healing chronic wounds. It will be administered twice weekly for 2 weeks then weekly

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
• Type I or II diabetes requiring medical treatment as determined by the physician
• The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) is a Wagner 1-5 DFU (see Appendix 9 for Wagner Classification) that is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces)
• For subjects with potentially multiple eligible DFUs, 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 0.5 cm2 and 50 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
• Presence of another wound that is concurrently treated and might interfere with treatment of the index wound by AutoloGel (malignancy in nearby wound)
• Ulcer not of DFU pathophysiology (e.g., venous, 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

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

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 20, 2013
• First Posted: March 22, 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)