DiabetesPhase 4HODFUNCT00953186
Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers
A Phase 4 study testing hyperbaric air and HBOT in people with Diabetes and Foot Ulcer, run by Mrs. Thelma Zoegas Foundation at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Foot Ulcer, Healing
- What is being tested?
- hyperbaric air and HBOT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2002to Jun 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hyperbaric Oxygen Therapy as Adjunctive Treatment in Diabetics With Chronic Foot Ulcers
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.
- Conditions
- Diabetes, Foot Ulcer, Healing
- Being tested
- hyperbaric air, HBOT
- Keywords
- Diabetes, Foot ulcer, Neuropathy, Ischemia
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric airDevice
air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber
HBOTDevice
100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber
| Study group | Role | What they receive |
|---|---|---|
| HBOT | Active comparator | 100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks Receives: Device: HBOT |
| Placebo | Placebo comparator | air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks Receives: Device: hyperbaric air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer healing
Measured: 3, 6, 9, 12, 18, 24 months
Secondary outcomes (3)
Amputationrate
Measured: 6, 12, 24 months
time to ulcer healing
Measured: 24 months
QoL
Measured: 3, 6, 12, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startJun 2002
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mrs. Thelma Zoegas Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Region Skåne Sweden, Gorthons Foundation Helsingborg Sweden
- Investigators
- Magnus Löndahl, MD, Principal investigator, Inst Clinical Sciences in Lund, Lund University, SwedenPer L Katzman, ass prof, MD, Study chair, Inst Clinical Sciences in Lund, Lund University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953186
- Sponsor's protocol ID
- Z012094
- Acronym
- HODFU
- Status last verified
- Aug 2009
- First submitted
- 28 Jul 2009
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17124820Londahl 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.
PubMed 20957342Londahl 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.
PubMed 20427683
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy as Adjunctive Treatment in Diabetics With Chronic Foot Ulcers
- ClinicalTrials.gov ID
- NCT00953186
- Acronym / sponsor ID
- HODFU / Z012094
- Conditions
- Diabetes, Foot Ulcer, Healing
- Keywords
- Diabetes, Foot ulcer, Neuropathy, Ischemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Mrs. Thelma Zoegas FoundationUniversity, hospital or other
- Collaborators
- Lund University, Region Skåne Sweden, Gorthons Foundation Helsingborg Sweden
- Study start
- Jun 2002
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBOT | Active comparator | Device: HBOT100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks |
| Placebo | Placebo comparator | Device: hyperbaric airair at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperbaric airair at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber | Device | Placebo |
| HBOT100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber | Device | HBOT |
Primary outcome
Ulcer healing
Time frame: 3, 6, 9, 12, 18, 24 months
3 secondary outcomes
Amputationrate
Time frame: 6, 12, 24 months
time to ulcer healing
Time frame: 24 months
QoL
Time frame: 3, 6, 12, 18, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
- Background: PubMed 17124820Londahl 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.
- Derived from this study: PubMed 20957342Londahl 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.
- Derived from this study: PubMed 20427683Londahl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Löndahl, MD principal investigator
Inst Clinical Sciences in Lund, Lund University, Sweden
Per L Katzman, ass prof, MD study chair
Inst Clinical Sciences in Lund, Lund University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hyperbaric air and HBOT in people with Diabetes and Foot Ulcer, run by Mrs. Thelma Zoegas Foundation at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer healing (time frame: 3, 6, 9, 12, 18, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00953186, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2011.