A Multi-Center, Randomized Trial Comparing the Effectiveness of APIC-PRP to Control, When Added to Standard of Care in the Treatment of Non-healing Diabetic Foot Ulcers

Cytonics Corporation0 sites274 target enrollmentOctober 2014

ConditionsDiabetic Foot Ulcer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Diabetic Foot Ulcer
Sponsor: Cytonics Corporation
Enrollment: 274
Primary Endpoint: Complete wound closure within 12 weeks
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Patients have a diabetic foot ulcer that is older than 4 weeks and has been treated with physician-selected standard of care treatment such as debridement, hydrogel or saline irrigation, primary dressing, and offloading will be randomized into one of two groups, the Standard of Care (SoC) or APIC-PRP + SoC. APIC-PRP has high level of platelets that produce growth factors that can help in wound healing.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

December 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cytonics Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Prior to the first clinical intervention, a signed Informed Consent Form (ICF) and Data Consent Form (DCF) must be obtained from the subject or legal representative
•Diagnosed with insulin-dependent or non-insulin-dependent diabetes (Type I or II, respectively), requiring medical treatment as determined by the physician
•Subjects will have only one diabetic foot ulcer on the target limb (referred to as the Index Ulcer)
•The Index Ulcer, classified using the University of Texas Wound Classification System (Appendix 7), is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces)
•Debrided ulcer size between 1 cm2 and 4 cm
•See Appendix 3 for instructions on wound area measurement
•DFU with a duration ≥ 1 month at first visit
•The target ulcer is free of clinical signs of infection, identified by inflammation (redness, warmth, swelling, tenderness, or pain) or purulent exudates (Lipsky et al, 2012).
•The patient meets Medicare/Medicaid eligibility requirements. Subject's ulcer extends through the dermis and into subcutaneous tissue (granulation tissue may be present) but without exposure of muscle, tendon, bone or joint capsule.
•Post-debridement, subject's wound is free of necrotic debris and appears to be made up of healthy vascularized tissue.

Exclusion Criteria

•Subject has inadequate venous access the blood draw required for APIC-PRP Administration. Subjects with PIC or IV access are preferred.
•Hemoglobin of less than 12 g/dL
•Inadequate amount of blood drawn to produce sufficient APIC-PRP. One complete APIC-PRP preparation requires 114ml of blood drawn per APIC-PRP preparation.
•Subject's ulcer has increased in size by \>50% during the run-in Screening period.
•If the subject's ulcer healed by 25% or more during the run-in Screening period they will be excluded.
•Presence of another wound that is concurrently treated and might interfere with treatment of the index wound by APIC-PRP (malignancy in nearby wound)
•Ulcer not of DFU pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
•The target ulcer demonstrates underlying osteomyelitis, defined as infection in the bone, identified by Fever, chills, or pain in the infected bone. Any exposed bone will be classified as osteomyelitis.
•Subject has a history of bleeding disorder.
•Any malignancy other than non-melanoma skin cancer requiring treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or corticosteroids less than 30 days before enrolment.

Outcomes

Primary Outcomes

Complete wound closure within 12 weeks

Time Frame: 12 weeks

The primary outcome expected for this study is an increase in the proportion of DFUs that have exhibited complete closure within 12 weeks between the APIC-PRP + SoC groups and SoC alone groups.

Secondary Outcomes

Improvement in wound healing trajectory within 12 weeks(12 weeks)
Improvement in wound healing for the patient to return to function over the 12 weeks(12 weeks)