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Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers (HODFU)

Primary Purpose

Diabetes, Foot Ulcer, Healing

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
hyperbaric air
HBOT
Sponsored by
Mrs. Thelma Zoegas Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Diabetes, Foot ulcer, Neuropathy, Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diabetes mellitus,
  • foot ulcer with duration > 3 months,
  • treatment at Diabetes foot clinic for > 2 months,
  • vascular surgical intervention had not been recommended for the affected lower limb.

Exclusion Criteria:

  • severe obstructive pulmonary disease,
  • malignancy and untreated thyrotoxicosis),
  • current drug or alcohol misuse,
  • vascular surgery in the lower limbs within the last two months,
  • participation in another study or suspected poor compliance.

Sites / Locations

  • Dept Anesthesiology, Helsingborg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

HBOT

Placebo

Arm Description

100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks

air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks

Outcomes

Primary Outcome Measures

Ulcer healing

Secondary Outcome Measures

Amputationrate
time to ulcer healing
QoL

Full Information

First Posted
July 28, 2009
Last Updated
November 7, 2011
Sponsor
Mrs. Thelma Zoegas Foundation
Collaborators
Lund University, Region Skåne Sweden, Gorthons Foundation Helsingborg Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT00953186
Brief Title
Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers
Acronym
HODFU
Official Title
Hyperbaric Oxygen Therapy as Adjunctive Treatment in Diabetics With Chronic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mrs. Thelma Zoegas Foundation
Collaborators
Lund University, Region Skåne Sweden, Gorthons Foundation Helsingborg Sweden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate if hyperbaric oxygen therapy heels more foot ulcers as compared to placebo in patients with diabetes mellitus and chronic foot ulcers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Foot Ulcer, Healing
Keywords
Diabetes, Foot ulcer, Neuropathy, Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HBOT
Arm Type
Active Comparator
Arm Description
100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks
Intervention Type
Device
Intervention Name(s)
hyperbaric air
Intervention Description
air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber
Intervention Type
Device
Intervention Name(s)
HBOT
Intervention Description
100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber
Primary Outcome Measure Information:
Title
Ulcer healing
Time Frame
3, 6, 9, 12, 18, 24 months
Secondary Outcome Measure Information:
Title
Amputationrate
Time Frame
6, 12, 24 months
Title
time to ulcer healing
Time Frame
24 months
Title
QoL
Time Frame
3, 6, 12, 18, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diabetes mellitus, foot ulcer with duration > 3 months, treatment at Diabetes foot clinic for > 2 months, vascular surgical intervention had not been recommended for the affected lower limb. Exclusion Criteria: severe obstructive pulmonary disease, malignancy and untreated thyrotoxicosis), current drug or alcohol misuse, vascular surgery in the lower limbs within the last two months, participation in another study or suspected poor compliance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Löndahl, MD
Organizational Affiliation
Inst Clinical Sciences in Lund, Lund University, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Per L Katzman, ass prof, MD
Organizational Affiliation
Inst Clinical Sciences in Lund, Lund University, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Dept Anesthesiology, Helsingborg Hospital
City
Helsingborg
ZIP/Postal Code
S 221 57
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
17124820
Citation
Londahl M, Katzman P, Nilsson A, Hammarlund C, Sellman A, Wykman A, Hugo-Persson M, Apelqvist J. A prospective study: hyperbaric oxygen therapy in diabetics with chronic foot ulcers. J Wound Care. 2006 Nov;15(10):457-9. doi: 10.12968/jowc.2006.15.10.26970.
Results Reference
background
PubMed Identifier
20957342
Citation
Londahl M, Katzman P, Hammarlund C, Nilsson A, Landin-Olsson M. Relationship between ulcer healing after hyperbaric oxygen therapy and transcutaneous oximetry, toe blood pressure and ankle-brachial index in patients with diabetes and chronic foot ulcers. Diabetologia. 2011 Jan;54(1):65-8. doi: 10.1007/s00125-010-1946-y. Epub 2010 Oct 19.
Results Reference
derived
PubMed Identifier
20427683
Citation
Londahl M, Katzman P, Nilsson A, Hammarlund C. Hyperbaric oxygen therapy facilitates healing of chronic foot ulcers in patients with diabetes. Diabetes Care. 2010 May;33(5):998-1003. doi: 10.2337/dc09-1754.
Results Reference
derived

Learn more about this trial

Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers

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