Quality of Life Clinical Trial
Official title:
Health-related Quality of Life Among Patients Amputated Due to Peripheral Arterial Disease
| Verified date | June 2019 |
| Source | Karolinska Institutet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
A prospective cohort study over the prosthetic use among patients amputated after vascular disease and the impact of their HRQoL.
| Status | Completed |
| Enrollment | 98 |
| Est. completion date | May 20, 2019 |
| Est. primary completion date | May 20, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients amputated at femoral, knee or tibial level due to peripheral arterial disease Exclusion Criteria: - Patients not able to provide informed consent - Patients not able to verbally express their experience of the amputation. - Patients that not speak Swedish |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Jonas Malmstedt |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Health related quality of life according to EQ-5D | The change in HRQoL between baseline and after 1 year. Measured with EQ-5D-3L | 1 year | |
| Secondary | Proportion of patients using prosthesis | Prosthesis use after a major amputation is measured with Stanmore mobility grade | 1 year after the amputation |
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