## Protocol Section
### Identification Module
**NCT ID:** NCT03356379

**Acronym:** PETRUS

**Brief Title:** Popliteal Artery Entrapment Syndrome & TRanscutaneoUS Oxymetry

**Official Title:** Application de l'oxymétrie Dynamique Pour le Diagnostic Des pièges artériels poplités

#### Organization Study ID Info
**ID:** 2017-AO1887-46
#### Organization
**Class:** OTHER_GOV
**Full Name:** University Hospital, Angers
### Status Module
#### Completion Date
**Date:** 2019-11-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-12-02

**Type:** ACTUAL

**Last Update Submit Date:** 2019-11-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-11-15

**Type:** ACTUAL

#### Start Date
**Date:** 2017-11-22

**Type:** ACTUAL

**Status Verified Date:** 2019-11

#### Study First Post Date
**Date:** 2017-11-29
**Type:** ACTUAL
**Study First Submit Date:** 2017-11-22
**Study First Submit QC Date:** 2017-11-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** University Hospital, Angers

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Aim of the study is to test the feasibility of transcutaneous oxygen pressure (TcPO2) recording in the diagnosis of popliteal entrapment syndrome (PES) in 30 patients with suspected PES and 30 asymptomatic control heathy subjects

**Detailed Description:** Patients suspected of PES and healthy cpontrols after detailled explanation of the protocol will have a recording of tcpO2 on both calves and will perform a series of elevation on foot in the standing position.

### Conditions Module

**Conditions:**

- Popliteal Entrapment Syndrome

**Keywords:**

- Diagnosis

- Peripheral artery disease

- sports

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** transcutaneous oximetry

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients suspected of PES will have a transcutaneous oximetry test during tiptoeing

**Intervention Names:**

- Diagnostic Test: Transcutaneous oximetry

**Label:** Patients

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Healthy asymptomatic athletes will have a transcutaneous oximetry test during tiptoeing

**Intervention Names:**

- Diagnostic Test: Transcutaneous oximetry

**Label:** Controls

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Controls

- Patients

**Description:** Measurement of TcpO2 on calves and chests. Calculation of the DROP index (decrease from rest of oxygen pressure)on both calves

**Name:** Transcutaneous oximetry

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Comparison of DROP value between PES patients and controls

**Measure:** Presence of a significant DROP decrease

**Time Frame:** 1 hour

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age over 18 years
* Insurance company alffiliation Symptoms consistent with PES (patients) or absence of symptoms (controls)

Exclusion Criteria:

* Refuse to participate Exclusion period from another protocole

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Angers

**Country:** France

**Facility:** CHU Angers

**Zip:** 49933

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital in Angers

**Name:** Pierre ABRAHAM, MD; PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M29213

- Name: Peripheral Arterial Disease

- Relevance: LOW

- As Found: Unknown

- ID: M2391

- Name: Popliteal Artery Entrapment Syndrome

- Relevance: HIGH

- As Found: Popliteal Entrapment Syndrome

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000083082

- Term: Popliteal Artery Entrapment Syndrome

- ID: D000013577

- Term: Syndrome

### Misc Info Module

- Version Holder: 2024-05-24
