diabetic foot ulcer MedDRA version: 12.1 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer
Conditions
Interventions
Product Name: DermaPro
Product Code: DPOCL
Pharmaceutical Form: Concentrate for cutaneous solution
Other descriptive name: Diperoxochloric acid
Concentration unit: mmol millimole(s)
Concentration typ
Sponsors
DermaTools Biotech GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Gender: male/female (of non-childbearing potential defined as being amenorrhoeic for longer than 2 years with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms) (1) ·Age: from 18 to 80 years to be included (2) ·Diabetic foot ulcer diameter in between 1,5-3,5cm after débridement (if indicated) wound stage Wagner grade I or II, Armstrong stadium A-C (for Wagner-Armstrong-Classification see Appendix 1) (3) ·Other wounds with impaired healing, e.g. decubitus ulcer, arterial and/or venous leg ulcer, Charcot's foot or malum perforans, may be present in the same patient but shall not be selected as targets for the present study (4) ·Diabetes mellitus; HbA1c to be controlled (5) ·Adequate perfusion of lower leg as determined for instance by the ankle brachial pressure index (>0.5), or by a more precise method (e.g. TcPO2 > 30 mmHg, pelvic/leg angiography, duplex sonography in discretion of the investigator) to exclude patients who require a revascularization therapy, examination results should be not older than 3 months (6) ·The patient must give written informed consent, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the patients participating in the study (7) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ·Local antibiotic therapy of the target wounds selected for the study (1) ·Suspicion of bone infection or osteomyelitis affecting the area of target wound (2)* ·Severe peripheral arterial occlusive disease in the pelvic region or lower extremities (3) ·Vascular reconstruction or angioplasty less than 3 months ago or planned revascularization procedure (4) ·Inability or unwillingness to be fitted with appropriate shoe gear or an off-loading device (if required) (5) ·Clinically significant abnormal laboratory values except those typical for the underlying diseases mentioned in the inclusion criteria (6) ·Severe or uncontrolled heart disease (7) ·Severe renal failure treated with dialysis (8) ·Severe hepatic disease (9) ·Concurrent illness or a condition that may interfere with wound healing other those mentioned in the inclusion criteria (e. g. carcinoma, haematological disease, vasculitis, connective tissue disease, alcohol neuropathy; history of or current drug or alcohol abuse) (11) ·Previous radiation of the region of the target wounds selected for the study (12) ·Exposure of any systemic immunosuppressive or cytostatic therapy during the previous 30 days prior to the study, this refers also to any kind of glucocorticoids (13) ·Severe psychiatric or neurological disorder (14) ·Incapability of giving informed legal consent (15) ·Co-worker, student, relative or spouse of the investigator (16) ·Participation in the study already before (17) ·Participation in another experimental clinical trial during the previous 30 days prior to the present study (18) ·HbA1c >9,5% If the patient does not meet this inclusion criterion, randomisation may be delayed and screening visit may be repeated. (19)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of clinical efficacy of DermaPro® after administration into the unhealing, open diabetic wounds characterised by reduction of wound area after 30, 60 and 90 days of treatment, time from onset of treatment until healing e.g. wound area covered entirely with connective tissue;Secondary Objective: Characterisation of safety of DermaPro® considering Adverse Events, laboratory parameters and vital signs Characterisation of subjective symptoms using visual analogue scores (VAS) for pain, itching, and well-being Evaluation of subjective clinical symptoms (prickling, heat sensation, cold sensation, numbness, furry feeling, smell, exudation) Investigation of clinical efficacy of DermaPro® concerning reduction of wound depth and wound volume during treatment Investigation of clinical efficacy of DermaPro® in terms of fractions of patients with 50% reduced wound area after 30, 60 and 90 days of treatment;Primary end point(s): Reduction of wound area after 30, 60, and 90 days of treatment in %, descriptive statistics (arithmetic and geometric means, CV, medians, min, max, SD) Time from start of treatment to entire closure of wound (arithmetic and geometric means, CV, medians, min, max, SD) Analysis of primary variables in terms of treatment effect is performed using mixed models (ANCOVA) including baseline covariate and addressing repeated measures by simple covariance patterns | — |
Countries
Germany, Latvia, Lithuania
Outcome results
None listed