Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Non-Healing Wounds

NCT02307448 | Terminated

• 1 other identifier: 10312014
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation plans to initiate the healing of chronic wounds by providing a concentrated platelet and growth factor therapy directly to the wound site by topical delivery. This therapy will be derived from autologous platelet rich plasma (PRP), an emerging surgical and wound care treatment. This investigation aims to demonstrate that patients with chronic, non-healing wounds treated with autologous PRP and standard medical care have a reduction in wound volume and improved healing rate that results in patient-centered clinically significant health outcomes as compared to patients treated with standard medical care only.

Conditions

Foot Ulcer Chronic; Skin Ulcer Venous Stasis Chronic; Pressure Ulcer

Outcome Measures

Primary Outcomes (1)

• Wound Closure

  The primary objective of this trial is to evaluate increasing the proportion of wounds with complete closure within 20 weeks of initial treatment

  20 weeks

Study Arms (2)

PRP Group

ACTIVE COMPARATOR

Patients will receive weekly PRP treatments

Procedure: Platelet Rich Plasma

Standard of Care

PLACEBO COMPARATOR

Patients will receive weekly standard of care.

Procedure: Standard of Care

Interventions

Platelet Rich Plasma PROCEDURE

Patients will receive weekly PRP treatments with standard of care.

Also known as: PRP

PRP Group

Standard of Care PROCEDURE

Patients will receive weekly standard of care.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age.
• Wound must be diagnosed as Diabetic Foot Ulcers (DFU), Venous Ulcers (VU), or Pressure Ulcers (PU) with duration greater than 30 days at first visit/patient screening.
• If more than one non-healing wound is present, the largest wound will be selected and must be at least 2cm in size.
• Wound must be classified as Wagner 1 - 3 on the Wagner classification system. Wagner's Classification System Grade 1 Superficial ulcer without subcutaneous tissue involvement Grade 2 Penetration through the subcutaneous tissue (bone, tendon, ligament or joint capsule) Grade 3 Osteitis, abscess or osteomyelitis Grade 4 Gangrene of the forefoot Grade 5 Gangrene of the entire foot
• There must be at least 2 cm between the index wound and other wounds; if all wounds are closer than 2 cm, the patient should not be enrolled (screen failure).
• Wound must be clinically non-infected (A swab or deep tissue culture shall be performed at the discretion of the provider).
• If a female of childbearing potential, the patient must have a negative serum pregnancy test at screening.
• Patient has the capacity to understand and consent to be in the study. Written informed consent must be obtained from either the patient or the patient's legally acceptable representative prior to screening activities.
• Platelet count ≥ 75,000 (according to CBC)
• Hemoglobin (Hgb) level \> 9 g/dL (according to CBC)
• Hematocrit (HCT or Ht) level \> 27% (according to CBC)
• Ankle-Brachial Index (ABI) Test \> 0.7

You may not qualify if:

• Male or female \<18 years of age
• Patients with known sensitivity to components of the PRP kit (calcium chloride, thrombin, collagen, acid citrate dextrose solution A (ACDA).
• Wound is not a Diabetic Foot Ulcers (DFU), Venous Ulcer (VU), or Pressure Ulcer (PU) at duration of greater than 30 days at first visit/patient screening.
• Wound that is classified as Wagner 4 - 5 on the Wagner classification system. Wagner's Classification System Grade 1 Superficial ulcer without subcutaneous tissue involvement Grade 2 Penetration through the subcutaneous tissue (bone, tendon, ligament or joint capsule) Grade 3 Osteitis, abscess or osteomyelitis Grade 4 Gangrene of the forefoot Grade 5 Gangrene of the entire foot
• There is less than 2 cm between the index wound and other wounds; if all wounds are closer than 2 cm, the patient should not be enrolled (screen failure).
• Wound is clinically infected. (A swab or deep tissue culture shall be performed at the discretion of the provider).
• Presence of non-treated osteomyelitis.
• If female, patient is pregnant, nursing or plans to become pregnant during the duration of the trial.
• Patients who are cognitively impaired and do not have a healthcare proxy.
• Platelet count \< 75,000 (according to CBC)
• Hemoglobin (Hgb) level ≤ 9 g/dL (according to CBC)
• Hematocrit (HCT or Ht) level ≤ 27% (according to CBC)
• Ankle-Brachial Index (ABI) Test ≤ 0.7
• Patient has lymphedema.
• Received electrostimulation, hyperbaric treatments, systemic corticosteroids, growth factors or any cell or tissue derived products for any wounds 30 days prior to entry into the study. (Except for patients receiving inhaled corticosteroid treatments for COPD)

Sponsors & Collaborators

• ACR Biologics, LLC: lead

Study Sites (1)

TriHealth Hatton Research Institute | Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Louis Thibodeaux, MD,FACCWS

  TriHealth Hatton Research Institute | Bethesda North Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 4, 2014
• Study Start: August 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

US (1)