Status:
TERMINATED
Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Non-Healing Wounds
Lead Sponsor:
ACR Biologics, LLC
Conditions:
Foot Ulcer Chronic
Skin Ulcer Venous Stasis Chronic
Eligibility:
All Genders
18+ years
Phase:
NA
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 d...
Detailed Description
This is a multicenter randomized controlled trial, with a single-blind parallel design. 1,500 subjects are planned to enroll in the study. Each subject will be assigned to the treatments in random ord...
Eligibility Criteria
Inclusion
- 2 Inclusion Criteria
- 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
- 3 Exclusion Criteria
- 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.
- Wounds smaller than 2cm will be excluded. Exclusion criteria do not include maximum wound size or age.
- 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)
- Received radiation therapy or chemotherapy within previous 3 months.
- Patient has inadequate venous access for repeated blood draw required for PRP preparation.
- Concurrent participation in a clinical trial in which an investigational agent is used.
Exclusion
Key Trial Info
Start Date :
August 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02307448
Start Date
August 1 2015
End Date
December 1 2022
Last Update
February 1 2023
Active Locations (1)
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1
TriHealth Hatton Research Institute | Bethesda North Hospital
Cincinnati, Ohio, United States, 45242