Health Condition 1: E085- Diabetes mellitus due to underlying condition with circulatory complications Health Condition 2: E085- Diabetes mellitus due to underlying condition with circulatory complications
Conditions
Interventions
Intervention1: PVR system medical device for application of CO2: Application of Co2 gas for Wound Healing through transcutaneous Therapy
Control Intervention1: PVR system medical device: Application o
Sponsors
PVR Med D O O
Eligibility
Inclusion criteria
Inclusion criteria: Patients with DM male and female aged 18 to 80 years Patients with DM with distal sensorimotor polyneuropathy who also have at least one or more foot ulcer that has been present for 1month or longer Patients with DM with DFU and DSPN with the following characteristics diabetic foot ulcer size 1 to 20 cm square according to University of Texas classification grade 1A 2A 3A 1C 2C 3C ulcer etiology arterial neuropathic or neuroischemic DFU without untreated osteomyelitis or progressive wound infection DSPN patients with diabetes mellitus type 1 or 2 with reduced or absent protective sensation in the foot Have An Ankle-brachial index greater than 0.3 Must be willing and able to attend daily CO2 therapy during the clinical trial period which means twenty therapies performed daily 5 times per week 4 weeks without weekends Be willing and able to sign an informed trial participation consent Be willing and able to maintain required offloading of affected limb by wearing a offloading footwear at all times when walking outside and indoors Be willing and able to reducing daily walking activities to only those necessary so that the pressure on the wound is as low as possible Have and maintain fair glycemic control during the study defined as HbA1c less than 8 percentage
Exclusion criteria
Exclusion criteria: COPD stage III or IV Patients with COPD stage I or II are suitable for treatment Chronic kidney disease CKD stage III IV And V Heart failure NYHA stage III or IV PAD stage III or IV according to Fontaine Myocardial infarction deep vein thrombosis Patients on anticoagulant therapy with well regulated blood clotting factor INR test can begin with treatments 6 months after infraction or thrombosis Progressive septic wound infection Untreated Osteomyelitis Anemia Acute infectious diseases Malignancy Pregnancy Hepatitis or HIV or severe hepatic impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective The primary objective of the study is to evaluate the efficacy of a four week therapy regimen consisting of 20 CO2 therapies on the wound healing rate Wound size reduction and wound closure Change in DFU wound area from baseline to the end of treatment visit expressed as absolute and percentage reduction and corroborated by the proportion number of ulcers achieving complete wound closure within the assessment period Timepoint: 20 sessions at 4 week period | — |
Secondary
| Measure | Time frame |
|---|---|
| Microvascular improvement DSPN improvement decrease in neuropathic pain improvement of protective sensorics Quality of life improvement Pain Depression To determine the proportion of subjects 12 months after the completion of the 20th CO2 or placebo therapy session who have achieved A reduction in the rate of wound recurrence A decrease in the rate of amputation A reduction in hospitalization frequency A decreased requirement for antibiotic therapy Timepoint: 20 sessions at 4 week period | — |
Countries
India
Contacts
Public ContactDr C Sheela Sasikumar
Dr RK Diabetic Foot and Podiatry Institute
Outcome results
None listed