Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03898869
Other study ID # BTK-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 29, 2019
Est. completion date January 2022

Study information

Verified date March 2019
Source Vilnius University
Contact Tomas Baltrunas
Phone +37052344519
Email tomas.baltrunas@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Patient with occluded below the knee arteries and chronic limb ischemia Rutherford class V-VI are enrolled.

During endovascular recanalisation procedure changes in tissue oxygen amount is recorded using near infrared spectroscopy (NIRS).

Primary hypothesis - NIRS can be used to determine sufficient amount of blood reaching the ulcered ishemic area.

Secondary hypothesis - NIRS can be useful in detecting early recoil after BTK recanalisation.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 2022
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender All
Age group 55 Years to 95 Years
Eligibility Inclusion Criteria:

- Critical limb ischemia Rutherford V-VI

- At least one artery below the knee is planned to revascularize

Exclusion Criteria:

- Blood oxygen saturation below 85% because of any comorbidities

- Life expectancy less than 12 months

- Unavoidable amputation above ankle

- Skin diseases preventing the use of NIRS

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Intraoperative NIRS monitoring
Near infrared spectroscopy non invasively used to register changes in tissue oxygen amount during endovascular revascularization

Locations

Country Name City State
Lithuania Vilniaus Miesto Klinikine hospital Vilnius

Sponsors (1)

Lead Sponsor Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Increase in oxygen amount sufficient for wound healing 12 months
Secondary Detection of early recoil after BTK revascularization 1 hour
See also
  Status Clinical Trial Phase
Completed NCT05023135 - DeepView SnapShot Portable (DV-SSP): Device Training Study
Recruiting NCT03459547 - Soft Peri-implant Tissue Around Different Abutment Materials N/A
Recruiting NCT05608187 - Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers Phase 2
Active, not recruiting NCT03649308 - Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting N/A
Recruiting NCT04596124 - Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze N/A
Completed NCT03285542 - Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty N/A
Recruiting NCT05689775 - Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
Recruiting NCT05474911 - PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY. N/A
Recruiting NCT04849143 - The Effectiveness of Stingless Bee Honey (Kelulut Honey) Versus Gel in Diabetic Wound Bed Preparation N/A
Completed NCT03596112 - The Difference in Wound Size Reduction Comparing Two Frequently Used Wound Dressings in Everyday Care N/A
Recruiting NCT05169814 - Micro/Nanobubbles (MNBs) for Treatment of Acute and Chronic Wounds Early Phase 1
Completed NCT04545476 - Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities N/A
Completed NCT06020157 - Comparison of Simple and Continuous Suture Techniques in Oral Surgery N/A
Recruiting NCT05133570 - Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities
Recruiting NCT04901325 - Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG) Phase 2
Withdrawn NCT03668665 - Influencing Wound Healing Through the Application of Hyaluronic Acid With Perfluorodecalin and Physalis Angulata Extract After Split Skin Removal From the Thigh - A Study in "Split Wound Design" Phase 3
Completed NCT03703479 - Effect of A-PRF After Removal of Wisdom Teeth N/A
Recruiting NCT03204851 - Microlyte Dressing in the Management of Wounds N/A
Recruiting NCT06117436 - Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients Phase 2/Phase 3
Completed NCT05618912 - Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment N/A