## Protocol Section
### Identification Module
**NCT ID:** NCT02233179

**Brief Title:** The Association Between Unprotected Standing, Walking and Wound Healing in Diabetes

**Official Title:** Body-worn Sensor Technology for Improving Diabetic Care During Activities of Daily Living

#### Organization Study ID Info
**ID:** 0900000701
#### Organization
**Class:** OTHER
**Full Name:** University of Arizona
### Status Module
#### Completion Date
**Date:** 2012-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-09-08

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-09-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-08

**Type:** ACTUAL

#### Start Date
**Date:** 2009-06

**Status Verified Date:** 2014-09

#### Study First Post Date
**Date:** 2014-09-08
**Type:** ESTIMATED
**Study First Submit Date:** 2014-08-08
**Study First Submit QC Date:** 2014-09-03
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Qatar National Research Foundation, Qatar

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Arizona

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of the study was to explore the association between activities of daily living ( measured using a body-worn sensor) on wound healing in diabetic patients. Since this was an exploratory study, there was no study hypothesis.

**Detailed Description:** Diabetes patients with active foot ulcers were recruited and monitored for activities of daily living while wearing an offloading device.

### Conditions Module

**Conditions:**

- Diabetic Foot

**Keywords:**

- Diabetic foot ulcer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 49

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** An offloading device that can be removed by the patients

**Intervention Names:**

- Device: Removable cast walker

**Label:** Removable Cast Walker

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** A removable cast rendered irremovable using instant total contact cast, so patients cannot remove offloading device.

**Intervention Names:**

- Device: Irremovable cast walker

**Label:** Irremovable Cast Walker

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Removable Cast Walker

**Description:** Offloading device that can be removed by patients.

**Name:** Removable cast walker

**Other Names:**

- Cast walker from Ossur, Reykjavik, Iceland

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Irremovable Cast Walker

**Description:** Offloading device that cannot be removed by patients.

**Name:** Irremovable cast walker

**Other Names:**

- Cast walker from Ossur, Reykjavik, Iceland

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Wound size was measured every week for 12 weeks

**Measure:** Wound size

**Time Frame:** 12 weeks

**Description:** Recorded using a body-worn sensor and measured every 4 weeks for 2 days.

**Measure:** Daily Physical Activities

**Time Frame:** 12 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* age 18 or older with non-infected, non-ischemic foot ulcers
* active neuropathic foot ulcer

Exclusion Criteria:

* major foot amputation
* active Charcot arthropathy
* ankle brachial index of 0.5 or less
* history of substance abuse within 6 months
* inability to walk 20m

**Maximum Age:** 68 Years

**Minimum Age:** 37 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tucson

**Country:** United States

**Facility:** University Medical Center

**State:** Arizona

**Zip:** 85724

#### Overall Officials

**Official 1:**

**Affiliation:** University of Arizona

**Name:** David G Armstrong, DPM, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003925

- Term: Diabetic Angiopathies

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000016523

- Term: Foot Ulcer

- ID: D000007871

- Term: Leg Ulcer

- ID: D000012883

- Term: Skin Ulcer

- ID: D000012871

- Term: Skin Diseases

- ID: D000048909

- Term: Diabetes Complications

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000003929

- Term: Diabetic Neuropathies

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17206

- Name: Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M19933

- Name: Diabetic Foot

- Relevance: HIGH

- As Found: Diabetic Foot

- ID: M18919

- Name: Foot Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M7120

- Name: Diabetic Angiopathies

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10883

- Name: Leg Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M15686

- Name: Skin Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26004

- Name: Diabetes Complications

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7124

- Name: Diabetic Neuropathies

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000017719

- Term: Diabetic Foot

### Intervention Browse Module - Ancestors

- ID: D000015853

- Term: Cysteine Proteinase Inhibitors

- ID: D000011480

- Term: Protease Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M40889

- Name: Calpastatin

- Relevance: HIGH

- As Found: Germany

- ID: M14343

- Name: Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M19609

- Name: HIV Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T4

- Name: Cysteine

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000033668

- Term: Calpastatin

### Misc Info Module

- Version Holder: 2024-05-24
