Plerixafor in Diabetic Wound Healing

NCT02790957 | Terminated Phase 2

• 1 other identifier: 3694/Ao/15
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; Wounds; Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• Wound healing rate

  Comparison of wound healing rates in the 2 groups, defined as the complete healing of wounds after 6 months from randomization

  6 months

Secondary Outcomes (6)

• Wound size

  6 months

• Oxygen tension

  6 months

• Perfusion

  6 months

• Surgical intervention

  6 months

• Stem cell mobilization

  6 months

Study Arms (2)

Plerixafor

EXPERIMENTAL

Single subcutaneous injection of Plerixafor (0.24 mg/kg)

Drug: Plerixafor

Placebo

PLACEBO COMPARATOR

Single injection of an equal volume of NaCl solution

Drug: Placebo

Interventions

Plerixafor DRUG

Single injection of 0.24 mg/kg Plerixafor

Also known as: Mozobil

Plerixafor

Placebo DRUG

Single injection of an equal volume of NaCl solution

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gian Paolo Fadini: lead
• University Hospital Padova: collaborator

Study Sites (1)

University Hospital of Padova

Padua, 35128, Italy

Location

Related Publications (1)

• Albiero M, D'Anna M, Bonora BM, Zuccolotto G, Rosato A, Giorgio M, Iori E, Avogaro A, Fadini GP. Hematopoietic and Nonhematopoietic p66Shc Differentially Regulates Stem Cell Traffic and Vascular Response to Ischemia in Diabetes. Antioxid Redox Signal. 2022 Apr;36(10-12):593-607. doi: 10.1089/ars.2021.0097. Epub 2022 Jan 4.

  PMID: 34538132 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Wounds and Injuries; Chronic Limb-Threatening Ischemia

Interventions

plerixafor

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Gian Paolo Fadini, MD PhD

  University of Padova

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 6, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: November 1, 2019
• Last Updated: December 19, 2019

Record last verified: 2019-12

Locations

IT (1)