NCT02328508

Brief Summary

This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (QOL) in diabetic foot ulcer (DFU) patients with diabetes.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2011

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 25, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

December 25, 2014

Last Update Submit

December 30, 2014

Conditions

Diabetic Foot UlcerDiabetes

Keywords

hyperbaric oxygen therapydiabetic foot ulcerwound healinginflammationglycemic controlamputationbacterial infectionquality of life

Outcome Measures

Primary Outcomes (1)

  • wound healing

    The Wagner Ulcer Grade Classification System for wound physiological index

    4 weeks

Secondary Outcomes (5)

  • inflammation index

    4 weeks

  • amputation rate

    4 weeks

  • survival rate of tissue in the affected limb

    4 weeks

  • bacteriological wound cultures

    4 weeks

  • glycemic control

    4 weeks

Study Arms (2)

hyperbaric oxygen therapy

EXPERIMENTAL

The experimental group received treatments in a hyperbaric chamber for 120-min per session, once per day, and five days per week for four consecutive weeks (20 treatment sessions).

Device: Hyperbaric oxygen therapy

Control

NO INTERVENTION

The control group received only routine care.

Interventions

Hyperbaric oxygen therapyDEVICE

HBOT was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions).

Also known as: HBOT
hyperbaric oxygen therapy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 20 years of age
  • a history of diabetes and a diagnosis of diabetic foot
  • a wound classification of Grade 3 or below
  • clear conscious and willing to participate in this study
  • a signed consent form

You may not qualify if:

  • less than 20 years of age, unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic FootDiabetes MellitusInflammationBacterial Infections

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Chen-Yu Chen, Master

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Registered Nurse

Study Record Dates

First Submitted

December 25, 2014

First Posted

December 31, 2014

Study Start

June 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

December 31, 2014

Record last verified: 2014-12