Plerixafor in Diabetic Wound Healing

• Status: Terminated
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic non-healing wounds represent a major source of morbidity, disability, and mortality in diabetic patients. Diabetes is the leading cause of non-traumatic limb amputations worldwide. Many patients with ischemic or neuroischemic wounds are not candidate to surgical/endovascular revascularization, owing to anatomical vascular reasons or for the underlying conditions and co-morbidities. Therefore, identification of novel medical treatment strategies to improve wound healing in diabetic patients is a major challenge for clinicians, researchers, and health care systems.

Defects in bone marrow (BM)-derive stem and progenitor cells, including EPCs (endothelial progenitor cells), contribute to diabetic complications. Stem cell mobilizing agents have been previously studied as an adjunctive therapy for critical limb ischemia and chronic non-healing wounds in diabetic and non-diabetic patients, as well as for the treatment of diabetic wound infections . Meta-analyses of such studies indicate that stem cell mobilization in these clinical conditions is safe and potentially effective in improving surrogate outcome measures and hard endpoints (such as rates of wound healing and amputation).

This study plans to evaluate whether a single injection of Plerixafor improves wound healing in diabetic patients with stage III-IV (neuro)ischemic wounds.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gian Paolo Fadini
• Collaborator: University Hospital Padova
• Treatments: JM 3100; Plerixafor

Criteria

Inclusion Criteria:

• Type 1 or type 2 diabetes

• Men of 18-85 years or post-menopausal women <85 years of age

• Presence of neuroischemic or ischemic diabetic wound(s) of the leg(s) / foot(s) Texas grade 3 or 4, with or without infection.

• Ability to provide informed consent.

Exclusion Criteria:

• Sepsis

• Dialysis or severe chronic kidney disease (eGFR <20ml/min/1.73 mq)

• Advanced liver disease (defined as cirrhosis or transaminases >3 times ULN)

• Clinically relevant abnormalities in white blood cell counts at baseline.

• Hematologic disorders (lymphoma, myeloma, acute or chronic leukemia, chronic myeloproliferative disorders)

• Known or highly suspected solid cancer

• Women with childbearing potential

• Known hypersensitivity to Mozobil (Plerixafor or its components)

• Inability to provide informed consent