I70.2
Conditions
Interventions
Group 1: Patients diagnosed with PAD (Peripheral Arterial Disease) at Fontaine stage =2B
with the following inclusion criteria:
- Chronic or recurring pain rated = 5 on the NRS (Numeric Rating Scale)
Sponsors
Neurochirurgische Klinik Universitätsklinik Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Chronic or recurrent pain rated = 5 on the NRS (Numeric Rating Scale) or VAS (Visual Analog Scale) for more than 3 months in the lower extremities at the time of inclusion • Diagnosis of PAD (Peripheral Artery Disease) with a stage of = 2B according to the Fontaine classification • Failure of conventional therapeutic measures for = 6 months • Capacity to provide informed consent in accordance with § 20, paragraph 2 of the German Medical Devices Act (MPG) • Ability to operate the SCS system • The patient is deemed suitable for SCS implantation • Age = 18 years
Exclusion criteria
Exclusion criteria: • BMI > 35 • Pregnancy or breastfeeding • Allergies or intolerances to components of the implantable neurostimulator • Acute myocardial infarction within the past 12 weeks • Circumstances that may impair the ability to operate the neurostimulator (e.g., compliance, motivation, physical mobility, social environment) • Participation in another study that would interfere with SCS therapy • Missing handwritten and dated informed consent or withdrawal of consent by the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain levels are evaluated to assess the effectiveness of SCS on PAD-associated pain. The following time points are considered: baseline before implantation, end of the trial phase, after permanent implantation, at 3 months ± 4 weeks, at 6 months ± 6 weeks, and at 12 months ± 12 weeks. - Percentage of change in average pain intensity in the primary pain area, measured using the NRS (Numeric Rating Scale) or VAS (Visual Analogue Scale). - Frequency of pain reduction of >30%, >50%, and >80% in average pain intensity on the NRS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoint Parameters: The additional parameters listed below will be collected to evaluate further effects of CL-SCS on PAD-associated symptoms, ulcer treatment, quality of life, functionality, and peripheral circulation at the following time points: baseline, end of the trial phase, after permanent implantation, at 3 months ± 4 weeks, at 6 months ± 6 weeks, and at 12 months ± 12 weeks. - PAD-associated symptoms - Change in scores according to the Fontaine or Rutherford classification: The percentage change will be evaluated based on the Fontaine and Rutherford classifications at the following time points: after 3 months ± 4 weeks, after 6 months ± 6 weeks, and after 12 months ± 12 weeks. - Change in scores according to the Wagner-Armstrong classification (for ulcer assessment) - Quality of Life and Functionality: - Change in scores based on the EQ-5D-5L. -Change in scores based on ODI, German Pain Questionnaire, PSQI (Pittsburgh Sleep Quality Index), VAS, BPI, ESS, SF36. - Change in scores based on the Wound Quality of Life (QuoL). - Change in scores based on the VascuQoL-6 scale. - Patient satisfaction will be assessed using the Subject Global Impression of Change (PGIC) scale at the following time points: 3 months ± 4 weeks, 6 months ± 6 weeks, and 12 months ± 12 weeks. - Change in patient satisfaction with conventional medical care (CMM) will be evaluated using a satisfaction scale at baseline. Peripheral Circulation: - Change in skin temperature - Changes in high-resolution Doppler ultrasound Additional Parameters: - Neurophysiological properties and stimulation programming features will be evaluated by analyzing data from the implanted SCS system (e.g., ECAP morphology, stimulation output settings, frequency). - Safety aspects will be assessed by evaluating device-associated adverse events (AEs) that occurred during the study period in subjects using the SCS. | — |
Countries
Germany
Contacts
Public ContactMeltem Ivren
Neurochirurgische Klinik - Universitätsklinikum Heidelberg
Outcome results
None listed