Health Condition 1: E104- Type 1 diabetes mellitus with neurological complications Health Condition 2: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention1: BTL-810-1: The BTL-810-1 applies cyclic external pressure to modulate macro- and microvascular flow in the treated limb.
The enrolled subjects will be assigned to one study group and wi
Sponsors
BTL India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Adults greater or equal 18 years with type 1 or type 2 diabetes 2 The subject needs to have at least one chronic diabetic foot ulcer of Wagner grade 1 or 2,greater than 4 weeks duration, at least 1 cm2 3 Adequate peripheral perfusion ABI greater or equal 0.7 and smaller or equal 1.2 in the leg with the target ulcer 4 Stable metabolic and systemic condition HbA1C smaller or equal 12 percent, hemodynamic stability 5 Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form 6 Subjects willing and able to comply with protocol requirements, including obtaining study-required assessments and returning for follow-up visits 7 Subjects willing and able to abstain from partaking in any new treatments other than the study procedure to treat ulcers and to maintain their regular standard care during study participation 8 Women of childbearing potential are required to use birth control measures
Exclusion criteria
Exclusion criteria: 1 ongoing pregnancy or breastfeeding 2 Previous treatment 30 days prior to enrollment of the condition with a VCT slash NPWT device,growth factors,hyperbaric oxygen,bioengineered tissue product or any other that,in the investigators opinion would interfere with the evaluation of the safety or efficacy of the study device. 3 Subject is enrolled in another investigational drug or device clinical trial or has participated in any other investigational study within 30 days prior to consent that can interfere with this study assessments as per investigators discretion. 4 Individuals undergoing concurrent therapy that,in the investigators opinion would interfere with the evaluation of the safety and efficacy of the study device.5 Any other disease or condition at the investigator discretion that may pose risk to the patient or compromise the study.6 Thrombosis and embolism or suspicion of these conditions.7 Aneurysm 8 Bleeding disorders or use of anticoagulant medication.9 Acute open wounds.10 Bleeding conditions.11 Purulent infections.12 Necrosis or gangrene.13 Septic conditions.14 Malignant tumours.15 Limb oedema of cardiac, renal, or hepatic origin.16 Thrombophilia e.g. Leiden mutation, use of hormonal contraceptives.17 Increased tendency to petechiae or haematomas.18 Mental conditions preventing safe enclosure of the limb in the cylinder.19 Hyperthermia, fever or systemic infections.20 Autonomic instability.21 Severe atherosclerosis.22 ischemic heart disease, myocardial damage.23 Severe hypertension or hypotension.24 General frailty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with greater or equal 50 percent target ulcer area reduction at the follow-up compared to baselineTimepoint: There will be a screening period of 5 days for the blood profile test, urine pregnancy test and ankle-brachial index measurement. The subjects will undergo 10 to 12 treatments and one follow-up visit spaced 2 to 4 days apart. The number of the treatments will depend on the principal investigators discretion. The approximate subject participation duration is 2 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change increase in wound-QoL-14 at the follow up compared to baseline 1 Therapy comfort during the therapy with BTL-810-1 device using the Therapy comfort 2 At least 80 percent of the treated subjects to report satisfaction level satisfied or very satisfied with the therapy outcome after the treatments using the Satisfaction QuestionnaireTimepoint: There will be a screening period of 5 days for the blood profile test, urine pregnancy test and ankle-brachial index measurement. The subjects will undergo 10 to 12 treatments and one follow-up visit spaced 2 to 4 days apart. The number of the treatments will depend on the principal investigators discretion. The approximate subject participation duration is 2 months. | — |
Countries
India
Contacts
Public ContactDr Karan Shetty
Tara healthcare Dr. Shettys Diabetic Foot and Wound Care Centre
Outcome results
None listed