Phase
Condition
Ulcers
Diabetes Mellitus Types I And Ii
Diabetes And Hypertension
Treatment
Platelet Rich Plasma
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female ≥ 18 years of age
Type 1 or Type 2 Diabetes
Grade 2, DFU, non-infected, below the ankle,1.0-12.0 cm2, present ≥ 30 day
Ulcer Size 1.0 cm2 to 12.0 cm2
Wound location will be distal to the malleolus, excluding between the toes, with noexposed capsule, tendon, or bone, and no tunneling, undermining, or sinus tracts, adepth of ≤ 5mm
If more than one non-healing wound is present, the selected ulcer will be thelargest and ≥ 1 cm2 in size.
At least 2.0 cm between the index wound and other wounds.
Study ulcer has been present for at least 30 days and has undergone the 14-day
Adequate vascular perfusion of the affected limb, as defined by at least one of thefollowing: Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2, Toe Pressure (TP) ≥ 30 mmHg,Transcutaneous partial pressure of oxygen (TcPO2) ≥ 30 mmHg, or skin perfusionpressure (SPP) ≥ 30 mmHg.
WIFI SCORE- wound grade 1, ischemia grade 0-1, and infection grade 0)
Screening Period of the standard of care with 20% or less wound closure.
No Clinical Signs of Infection at the wound site or the affected limb.
Post-debridement without signs of necrotic tissue.
Normal Platelet count ≥ 105,000 and <450, 000 (according to CBC)
Hemoglobin (Hgb) ≥10 g/dL and Hematocrit (HCT) ≥ 27% (according to CBC)
Controlled glucose level HbA1C ≤ 12%, with active treatment being conducted toreduce the value to by a primary provider or endocrinologist
No Chronic Renal Failure (CRF); Estimated glomerular filtration rate (eGFR) ≥ 15
PT/PTT - INR between 2.0-3.0 (with blood thinners).
Nutritional Status with no severe protein deficiency, Pre-albumen >15 mg/dL
Demonstrated adequate offloading using DH Walker boot with Plastazote Insole (ORequivalent off-loading device).
If a female of childbearing potential, must have a negative serum or urine pregnancytest at screening and use contraception or abstinence during trial.
Male subjects agree to use contraception or abstinence during the trial.
The subject has provided written informed consent before any screening proceduresand agrees to comply with study procedures and requirements.
Exclusion
Exclusion Criteria:
Life expectancy is less than 12 months.
Anemia Hgb ≤ 10 g/dL and HCT ≤ 27%.
Ulcers of other than diabetic foot pathophysiology.
Participation in another clinical trial involving a device or a systematicallyadministered investigational study drug or treatment within 30 days.
Documented sepsis, proven with blood cultures, within 2 weeks of the trial or duringthe Screening Phase.
Soft tissue infection at the designated ulcer or the same extremity within 2 weeksof the time of screening.
Osteomyelitis at the designated wound site; using ESR ≥ and /or CRP ≥ 7.9 mg/d as ascreen.
CKD Level G5: Chronic Renal Failure (CRF) sufficient to require dialysis.
Religious constraints to using blood products, including autologous blood.
Alcohol or substance abuse (other than tobacco) within 2 months before enrollment.
Blood-borne or communicable diseases that would likely prevent full participation inthe trial (e.g., HIV, AIDs, COVID, TB).
Participation in another clinical trial involving a device or a systematicallyadministered investigational study drug or treatment within 30 days of initiatingthe trial.
The subject has severe lymphedema (Stage 3) where the individual cannot lift theextremity on their own secondary to the amount of edema and fluid weight.
The subject is undergoing hemodialysis.
Subjects who are cognitively impaired, unable to understand the informed consent, orhave a health care proxy.
Subjects with sickle cell anemia, thrombocytopenia, leukemia, or blood dyscrasia.
History of problems with coagulation, abnormal thrombocytes (platelets), orreceiving heparin intravenously; subjects taking coumadin, aspirin, clopidogrel, orother oral anti-coagulants are not excluded.
Anemia where weekly blood draws of 12 or 23 per week may not be tolerated.
Received electrostimulation, hyperbaric treatments, growth factors, or any cell ortissue-derived therapy for any wounds 30 days before entry into the study.
Systemic corticosteroids, (except for subjects receiving inhaled corticosteroidtreatments for asthma or COPD) 30 days before entry into the study.
Received within 30 days before the study or scheduled to receive medications ortreatments known to interfere with or affect the rate or quality of wound closure (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapywithin the past 12 months, dialysis, radiation therapy to the treatment area,vascular surgery, angioplasty, or thrombolysis.
Received radiation therapy or chemotherapy within the previous 3 months.
Subjects with known sensitivity to blood components such as those in the PRF kit.
The subject has inadequate venous access for repeated blood draws required for thePRP preparation.
Study Design
Study Description
Connect with a study center
WoundCentrics Wound Care & Hyperbarics -Corpus Christi - Shoreline
Corpus Christi, Texas 78404
United StatesActive - Recruiting
Woundcentrics Wound Care Center At Corpus Christi South
Corpus Christi, Texas 78414
United StatesActive - Recruiting
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