## Protocol Section
### Identification Module
**NCT ID:** NCT06435143

**Acronym:** IESPI

**Brief Title:** Validation and Usability Study of Intermittent Electrical Simulation in Management of Pressure Injuries Stages 1 and 2

**Official Title:** Validation and Usability Study of Intermittent Electrical Simulation (Prelivia) IES in the Management of Pressure Injuries Stage 1 and Stage 2

#### Organization Study ID Info
**ID:** H24-00304
#### Organization
**Class:** OTHER
**Full Name:** University of British Columbia
### Status Module
#### Completion Date
**Date:** 2024-11-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Providence Health & Services

#### Lead Sponsor

**Class:** OTHER

**Name:** University of British Columbia

#### Responsible Party

**Investigator Affiliation:** University of British Columbia

**Investigator Full Name:** Lisa Maks

**Investigator Title:** Diabetes Clinical Nurse Specialist, Adjunct Professor UBC School of Nursing

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The focus of this study will be early stage pressure ulcers, which can quickly progress to stage 3, 4 or deep tissue injury The proposed study explores the feasibility of intermittent electrical stimulation (IES),Prelivia, a novel, non-invasive technology in the management of stage 1 and 2 pressure ulcers.

**Detailed Description:** Pressure ulcers (also known as pressure injuries or bedsores) constitute a major morbidity in critically ill patients due to immobilization, deranged tissue perfusion, and poor nutrition. It is estimated that the prevalence of pressure injuries is 2.2 to 23.9 percent or higher, depending on the hospital environment, significantly contributing to nosocomial risk and healthcare costs.

Particularly, they are one of the most common complications among people with limited mobility is increased pressure on certain areas of the body causing reduced blood flow and damage to the skin.

There has been extensive research that shows electrical stimulation can be useful in pressure ulcer treatment. (Arora et al, 2020) (5) Electrical stimulation is provided by an electrical current, which can be applied in many ways.

The study intervention applies Intermittent Electrical Stimulation (IES) to the affected area through surface electrodes. The device invokes muscle contractions for 10 seconds every 10 minutes, emulating the subconscious adjustments performed by able- bodied individuals in response to discomfort when seated or lying down. Animal studies demonstrate that IES reduces internal pressure at bone-muscle interfaces (the hypothesized mechanism for injury development), increases tissue oxygenation in surrounding areas, and reduces or eliminates deep tissue injury in muscles subjected to prolonged loading (Appendix A). (6) (L. Solis et al., 2008) (7) Clinical studies support the safety, feasibility, and general acceptability of gluteal IES in human participants. (Appendix B) (Ahmetovic et al., 2015) (8) (Kane et al., 2017) (9) This technology has been studied and has shown, with strong evidence, the capacity of IES to prevent sacral and ischial pressure injuries.

Prelivia uses RHT's patented Intermittent Electrical Stimulation (IES) technology which counteracts damaging tissue compression and increases blood flow to parts of the body that are at risk. Prelivia acts by mimicking the physiological micro-contractions that normally occur in mobile individuals when they fidget or shift their weight. Prelivia works by restoring subconscious muscle contractions and movements, or a 'fidgeting' movement that able-bodied individuals are able do. These muscle contractions increase tissue perfusion - the process in which metabolic waste is removed and fresh blood, oxygen, and nutrients are brought into the tissue. The target muscles(such as the glutei maximi) are electrically stimulated for 10 seconds every 10 minutes to restore adequate tissue perfusion to the surrounding tissue.

The system consists of a battery-powered stimulator (Prelivia Stimulator) and disposable hydrogel electrodes. Prelivia's streamlined design, simple application, and low cost make it the ideal addition to existing standard of care procedures.

Prelivia is the only device on the market that addresses poor circulation and low oxygenation in compressed areas. Current pressure injury preventative interventions rely on either temporarily relieving pressure (nurses turn patients every 2 hrs) , creams, or redistributing pressure (specialized mattresses, cushions, etc.). However, neither of these interventions restore blood circulation, tissue oxygenation, or tissue perfusion.

Primary objective: To evaluate users' interaction with the device, safety and tolerability by patients when wearing Prelivia IES during management of pressure injuries stage 1 and 2 during their stay in the hospital, up to 30 days, until patient death or discharge whatever comes first.

Secondary objective : Compare the status and healing time of stage 1 and 2 pressure injuries matched with the historic controls, via retrospective data review. Historic controls will involve consideration of various factors:

Patients with documented stage 1 and 2 pressure injuries matched according to the age range, gender, location of pressure injury(ies), Body mass Index and comorbidities.

Data will be requested from the Providence Healthcare Integrated Health informatics Datalab.

Exploratory objective: Develop high level health economic model for pressure injury cost savings.

### Conditions Module

**Conditions:**

- Pressure Injury

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** This is a feasibility study of testing Prelivia in an in-patient setting

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patient admitted to hospital with a confirmed stage 1 and 2 pressure injuries. Prelivia device will be applied to skin around pressure injury. Intermittent electrical stimulation will be administered for 10 seconds every 10 minutes to improve blood flow and muscle contraction to the area, simulating movement

**Intervention Names:**

- Device: Prelivia

**Label:** Patient with pressure injury stage 1 and stage 2

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patient with pressure injury stage 1 and stage 2

**Description:** Pad applied to skin provide electrical stimulation for 10 seconds every 10 minutes

**Name:** Prelivia

**Other Names:**

- Intermittent electrical stimulation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Will assess using qualitative questionnaire for both nursing staff and patient as to comfort and ease of use.

**Measure:** To evaluate users' interaction with the device, safety and tolerability by patients when wearing Prelivia IES during management of pressure injuries stage 1 and 2 during their stay in the hospital

**Time Frame:** 30 days

**Description:** Will perform an initial assessment of the wound (e.g. size, narrative description) and compare this pre-intervention with post-intervention after a maximum of 30 days of wear time.

**Measure:** Compare the status and healing time of stage 1 and 2 pressure injuries matched with historical controls via retrospective data review. Historic controls will involve consideration of a various factors:

**Time Frame:** 30 days

**Description:** Measurement of cost to treat patients that developed a severe pressure ulcer compared to those that did not.

**Measure:** Exploratory objective: to develop high level health economic model for pressure injury cost savings

**Time Frame:** 120 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria: Willing and able to provide written informed consent to participate and wear Prelivia for the duration of the study but not longer than 30 days Patients with new or already established stage 1 and 2 pressure injuries BMI \<40 Pressure injury location sacral/ischial region

-

Exclusion Criteria:

* existing pressure injury above stage 2 and injuries classified as DTI or unstageable continuous neuromuscular blocking drugs \& myasthenia gravis: may prevent the ability of IES to induce muscular contraction
* electrical stimulation to induce muscular contraction
* presence of permanent pacemaker or AICD, and for those with external wires after cardiac surgery, those who are using or at high risk for the development of a requirement for an external pacemaker
* unstable spinal, pelvic, or hop fractures that may be displaced by a forced contraction (for sacral and ischial ulcers)
* rhabdomyolysis
* skin breakdown or malignant skin involvement over the effected regions that would preclude the use of surface electrodes
* any implantable electrostimulation device
* have pacemaker or any other implantable neurostimulation devices,
* if your pressure injury is above stage 2, or
* if you are receiving neuromuscular blocking drugs,
* if you have myasthenia gravis,
* if you have unstable spinal, pelvic, or hip fractures that may be displaced by a forced contraction or
* if you are wearing an incontinence brief and have frequently loose bowel movements

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** lmaks@providencehealth.bc.ca

**Name:** Lisa J Maks, MN

**Phone:** 604-816-6523

**Role:** CONTACT

**Contact 2:**

**Email:** mdayrit@providencehealth.bc.ca

**Name:** Melodee Dayrit, BScN

**Phone:** 604-682-2344

**Phone Ext:** 62711

**Role:** CONTACT

### IPD Sharing Statement Module

**Description:** Unidentifyable research data will be shared with other team members

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012883

- Term: Skin Ulcer

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M834

- Name: Crush Injuries

- Relevance: HIGH

- As Found: Pressure Injury

- ID: M6870

- Name: Pressure Ulcer

- Relevance: HIGH

- As Found: Pressure Injury

- ID: M17206

- Name: Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

- ID: M15686

- Name: Skin Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003668

- Term: Pressure Ulcer

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000071576

- Term: Crush Injuries

### Misc Info Module

- Version Holder: 2024-05-31
