Clinical trial NCT01816633: Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers
Official title: A Multi-Center, Prospective, Cohort Trial Comparing the Effectiveness of AutoloGel Therapy to Usual and Customary Care in All Wagner Grades of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Foot Ulcers
Keywords: non healing wound
Lead sponsor: Cytomedix
Sponsor class: INDUSTRY
First posted: 2013-03-22
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: AutoloGel is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. Prospective observational studies of the effectiveness of AutoloGel have demonstrated promising results in regard to the healing of DFUs, including severe Wagner grade 3 and 4 ulcers. 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 will be treated using AutoloGel to determine the time to heal at 12 weeks. Comparison will be made with a case-matched concurrent cohort of patients receiving undefined Usual and Customary Care (UCC).

Eligibility criteria: Inclusion Criteria:

1. Medicare/Medicaid eligible
2. ≥18 years of age
3. Type I or II diabetes requiring medical treatment as determined by the physician
4. 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)
5. 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)
6. Debrided ulcer size between 0.5 cm2 and 50 cm2
7. Demonstrated adequate offloading 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 the index wound by AutoloGel (malignancy in nearby wound)
3. Ulcer not of DFU pathophysiology (e.g., venous, 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.

Primary outcomes:
measure: Time to heal
timeFrame: 12 weeks
Secondary outcomes:
measure: Ulcer recurrence
timeFrame: 1 year
measure: Incidence of amputations
timeFrame: 1 year
measure: Proportion of completely healed ulcers
timeFrame: 12 weeks
measure: W-QOL (Quality of life with Chronic Wounds) score
timeFrame: 12 weeks
measure: Number of patients with adverse events as a measure of tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Arcadia
country: United States
state: California
city: Cumming
country: United States
facility: HyperBarxs at Northside Forsyth
state: Georgia
Study officials:
References: