Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tissue Repair Company
With
Cardium Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 18 years or older
Diagnosis of diabetes mellitus (Type I or II) requiring insulin or hypoglycemic agents to control blood sugars.
Cutaneous, lower extremity ulcer of the foot that is ≥1.5 and ≤10.0 cm² in size and Wagner Classification Grade 1 in appearance. Note - Ulcer area must be calculated at Screening Visit and on the Treatment Day (Day 1) using measurements obtained by tracing the ulcer perimeter after debridement to confirm patient eligibility prior to randomization.
Documented ulcer presence for ≥6 weeks prior to signing the informed consent form
Recently debrided ulcer (within 2 weeks from screening visit)
Ulcer free of all necrotic soft tissue
Affected limb transcutaneous partial pressure oxygen (TcpO2) \>40mmHg; or a toe pressure ≥40mmHg; or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) at screening
Inability to perceive 10 grams pressure using a Semmes-Weinstein 5.07 monofilament in the peri-ulcer area
Willing to adhere to wearing off-loading orthopedic shoe for up to 16 weeks (i.e., through 2 weeks after ulcer closure) starting on Day -14 (the first day of the screening run-in period)
Willing to adhere to wearing customized shoes during the durability phase of the study
Females of child-bearing potential must have a negative serum beta human chorionic gonadotropin hormone (ßhCG) test result from a sample obtained in the 7 days prior to Treatment Day 1 and be neither breastfeeding nor intending to become pregnant during the study
All individuals (study patients/partners) of childbearing potential must agree to use a method of contraception deemed acceptable by the Investigator or agree to remain abstinent throughout the study
Be able to understand and sign an informed consent form before entering into the study, and must be willing to comply with all study procedures
You may not be if
Any unstable medical condition judged by the Investigator or Medical Monitor that would cause the study to be detrimental to the patient
Hemoglobin Alc (HbA1c) test result of \>12% documented at the Screening Visit
Ulcers caused primarily by untreated vascular insufficiency; or ulcers with an etiology not related to diabetes
Ulcers on the heel
More than three ulcers on the target lower extremity
The ulcer to be studied is not anatomically distinct from another ulcer(s) (i.e., separated by \<1 cm from another ulcer or would interfere with standard of care treatment of another ulcer). Only a single ulcer can be treated in this study.
Ulcers which decrease in area by \>30% during the screening 2-week run-in period
Ulcers with underlying osteomyelitis
Patients presenting with the clinical characteristics of cellulitis at the ulcer site (suppurative inflammation involving particularly the subcutaneous tissue, often mild erythema, tenderness, malaise, chills and fever)
If either beta hemolytic streptococci (in any amount) or total bacterial load of \>1e6 CFU/gram of tissue is present in the screening biopsy sample at the ulcer site, the patient should be given a single 7-day course of topical antibiotics and then redebrided and biopsied for quantitative culture. A second biopsy exceeding the limits above will result in exclusion from the study due to the high risk of local infection than may adversely affect ulcer closure.
Revascularization surgery on the leg with the wound to be treated ≤8 weeks prior to signing the informed consent form
Surgery to lengthen Achilles tendon on the leg with the wound to be treated ≤8 weeks prior to signing the informed consent form
Necrosis, purulence, or sinus tracts that cannot be removed by debridement on foot to be treated
Needs concurrent topical antimicrobials to treat the ulcer site, or received such therapies within 7 days prior to signing the informed consent form
Received dermal substitute or living skin equivalent (e.g., Dermagraft® or Appligraf®) within 30 days prior to signing the informed consent form
Received prior PDGF-BB (Regranex®/becaplermin) therapy within 30 days prior to signing the informed consent form
Has known sensitivity to products of bovine origin
Life expectancy of less than 12 months
Patients with a definite diagnosis of any immunodeficiency disorder
Viral hepatitis \[patient must have a negative hepatitis B surface-antigen (HBsAg) and hepatitis C antibody (HepCAb) test results obtained within 2 weeks prior to the Treatment Day (Day 1)\]
Active, uncontrolled connective tissue disease
Renal failure as defined by serum creatinine \>2.5 mg/dL
Liver function studies (e.g., AST, ALT) that are \>2.0 times upper limit of normal
Poor nutritional status as measured by serum albumin \<3.0 g/dL
Active cancer or a history of cancer in the 5 years prior to signing the informed consent form (however, history of basal cell carcinoma is allowed)
Active (i.e., recent onset of erythema, edema, and increased temperature of the foot with normal radiographs ) Charcot or other structural deformity that would prevent adequate off-loading of the study foot
Treatment with any systemic corticosteroid, immunosuppressive chemotherapeutic agent, antiviral, or previous/current radiation therapy to lower extremity within 30 days prior to signing the informed consent form
Received another investigational drug or biologic within 30 days prior to signing the informed consent form or currently participating in an investigational drug or biologic study
A psychiatric condition or chronic alcohol or drug abuse problem, determined from the patient's medical history, which in the Investigator's opinion may pose a threat to patient compliance
History of non-compliance with treatment or clinical visit attendance (i.e., this study requires that patients will comply with the protocol and ulcer care regimen)
Clareo Health | Phase 2b Study of GAM501 in the Treatment of Diabetic Ulcers of the Lower Extremities
