Study with HO/03/03 in the treatment of Plantar Neuropathic Diabetic Foot Ulcer.
- Registration Number
- CTRI/2009/091/000546
- Lead Sponsor
- HealOr Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 146
1. Age between 18 and 80 years, extremes included;
2. Diagnosed with Diabetes Mellitus Type 1 or Type 2;
3. Having a documented single non-healing Plantar Neuropathic Diabetic Foot Ulcer (per subject) with a minimal duration of 4 weeks prior to the informed consent signature;
4. Ulcer size at randomization between 1.0 cm2 to 10 cm2, extremes included;
5. Single, full thickness ulcer on the study foot, depth is no more than exposed muscle ? Wagner grade 1 (does not involve exposed tendon,ligament, joint capsule, fascia or bone, no abscess or osteomyelitis);
6. Glycosylated Haemoglobin A1c (HbA1c) <= 12%;
7. Ankle to Brachial Index (ABI) on study foot:
1. 0.7 <= ABI <= 1.2 or
2. ABI > 1.2 and toe pressure > 50 mm Hg
(ABI measured by Doppler; toe blood pressure measured in a vascular lab);
8. Diabetic Neuropathy is confirmed by neurological testing
9. Subject should be available for the entire study period, and be able and willing to adhere to protocol requirements;
10.Subject has signed the informed consent form prior to any study protocol related procedure;
1. Anamnesis of current or recent past (within the last 2 years) abuse of alcohol, barbiturates, benzodiazepines, amphetamines, narcotics, cocaine,psychoactive drugs or other abused substances (licit or illicit) that will
interfere with treatment compliance;
2. Use of growth factors, skin graft or participation in an investigational study within the last 30 days prior to the beginning of the screening period;
3. Females who are pregnant, lactating, of child-bearing potential, or postmenopausal for less than 2 years and not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a blood-based pregnancy test.
4. Have a documented medical history of HIV, HBV or HCV;
5. Have a documented medical history of a significant cardiac, pulmonary, gastrointestinal, endocrine (other than Diabetes Mellitus type 1 or 2), metabolic, neurological, hepatic or nephrologic disease and/or receiving dialysis;
6. Anaemia (Haemoglobin < 9 gram/dL for females or Haemoglobin < 10 gram/dL for males) or White Blood Cells count > 11,000/μL or Platelets count < 100,000/μL or impaired renal function (Creatinine > 3 mg/dL) or
liver function tests > 3 times normal lab values or any indication of malnourishment (Albumin < 2.8 g/dL) or any other clinically significant biochemistry, haematology and urinalysis tests;
7. Had any clinically significant illness during the last 4 weeks prior to the screening period;
8. Have a current malignancy or a past malignancy in the last 5 years other than Basal Cell Carcinoma or is treated by radio/chemotherapy;
9. Ulcer involves or exposes tendon, ligament, joint, fascia or bone at wound site;
10.Have any signs of clinical infection in the wound (which could be linked to raised body temperature), abscess, osteomyelitis, necrosis or erythema);
11.Had any antibiotic treatment during the screening period;
12.Had evidence of infection or osteomyelitis on a plain foot x-ray at screening;
13.Is bed-ridden or unable to come to the clinic;
14.Have more than one non-healing Diabetic Foot Ulcer per subject;
15.Plantar Neuropathic DFU is located on an active Charcot foot;
16.Have hind foot ulcer or have a foot deformity/condition preventing the use of offload footwear;
17.Had a leg revascularization surgery within the last 6 months or be a candidate for revascularization surgery during the course of the study;
18.Glucocorticosteroid treatment (Prednisone >10 mg/day or its equivalent);
19.Ulcer decreased in size ≥ 30% during the screening period in the 2 weeks from size measurement after debridement to size at randomization;
20. Inability to stop alternative wound healing treatment (e.g. Becaplermin or other topical products) following debridement;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete Ulcer ClosureTimepoint: At up to 14 weeks scored dichotomously:<br>0 - 'No Complete Closure'<br>1 - 'Complete Closure'<br>
- Secondary Outcome Measures
Name Time Method -Time to Complete Closure and <br>Absolute change in Ulcer Area as measure by size at baseline subtracted from size at either: Complete closure or End of trial (or last observed value; LOV)Timepoint: depends on patient