NCT00953186

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_4 diabetes

Geographic Reach
1 country

1 active site

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, 2002

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
Last Updated

November 8, 2011

Status Verified

August 1, 2009

Enrollment Period

6.9 years

First QC Date

July 28, 2009

Last Update Submit

November 7, 2011

Conditions

DiabetesFoot UlcerHealing

Keywords

DiabetesFoot ulcerNeuropathyIschemia

Outcome Measures

Primary Outcomes (1)

  • Ulcer healing

    3, 6, 9, 12, 18, 24 months

Secondary Outcomes (3)

  • Amputationrate

    6, 12, 24 months

  • time to ulcer healing

    24 months

  • QoL

    3, 6, 12, 18, 24 months

Study Arms (2)

HBOT

ACTIVE COMPARATOR

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

Device: HBOT

Placebo

PLACEBO COMPARATOR

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

Device: hyperbaric air

Interventions

hyperbaric airDEVICE

air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber

Placebo
HBOTDEVICE

100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber

HBOT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept Anesthesiology, Helsingborg Hospital

Helsingborg, S 221 57, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 17124820BACKGROUND

  • 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.

    PMID: 20957342DERIVED

  • 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.

    PMID: 20427683DERIVED

MeSH Terms

Conditions

Diabetes MellitusFoot UlcerIschemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeg UlcerSkin UlcerPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Magnus Löndahl, MD

    Inst Clinical Sciences in Lund, Lund University, Sweden

    PRINCIPAL INVESTIGATOR

  • Per L Katzman, ass prof, MD

    Inst Clinical Sciences in Lund, Lund University, Sweden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2009

First Posted

August 6, 2009

Study Start

June 1, 2002

Primary Completion

May 1, 2009

Study Completion

June 1, 2009

Last Updated

November 8, 2011

Record last verified: 2009-08

Locations

SE(1)