Diabetic Foot UlcersNCT02313428
Topical Oxygen Therapy for Diabetic Wounds
A study testing Topical Oxygen Chamber for Extremities in people with Diabetic Foot Ulcers and Wound, run by Indiana University at 1 site in United States.
Trial summary
This is a pilot study which is intended to collect data to calculate an adequate sample size for a larger registered clinical trial. Eleven subjects were enrolled at The Ohio State University; we intend to enroll 29 more subjects at Indiana University. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers, Wound
- What is being tested?
- Topical Oxygen Chamber for Extremities
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 5 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age >18 years
- Able to give informed consent, willing and able to visit the hospital and CWC for regular treatment and follow-up visits.
- Diabetic
- -Chronic wound OR Foot Ulcer:
- Ulcer present by history ≥ 4 weeks at time of enrollment
- Compliant with standard wound care regimen
Show all 15Show fewer
- IF foot wound, Wagner grade 1 and 2, OR Wagner grade 3
- Ulcer size: 0.6 cm2 to 20 cm2 and has not decreased in size by more than 30% in previous 2 weeks of the enrollment visit
- Adequate circulatory status, as evidenced by any of the following:
- Ankle Brachial Index (ABI) ≥0.7 - ≥ 1.20
- If ABI non-compressible (ABI >1.2), then toe brachial Index (TBI)>0.5
- SPP > 30mmHg
- TcOM > 30mmHg
- At least 4 weeks since revascularization procedure, if one has been performed
- Able to complete Topical Oxygen Therapy 4 day/week for 16 weeks (must be able to remove existing wound dressing and apply TO2 Boot/treatment, and then re-dress wound)
Who cannot join
- Ulcer in area of radiation treatment.
- Active malignancy at site of ulcer
- Current treatment with wound VAC or weekly compression dressing
- Untreated infection at site of ulcer (i.e. cellulitis or osteomyelitis)
- If acute osteomyelitis has been diagnosed, patient may be enrolled only after the infection has been controlled. Including:
- Debridement of infected bone if necessary
- Patient has received at least 2 weeks of appropriate antibiotics
- ABI < 0.7 or > 1.2
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Effects of Topical Oxygen for Diabetic Wounds
This is a pilot study which is intended to collect data to calculate an adequate sample size for a larger registered clinical trial. Eleven subjects were enrolled at The Ohio State University; we intend to enroll 29 more subjects at Indiana University. Due to the small sample size this study will primarily be a feasibility study that will attempt to measure and evaluate differences in the relative theoretical costs of the intervention of topical oxygen therapy on this population and subsequently compare outcomes in areas such as overall health improvements and cost effectiveness.
Read the detailed description
There are a total of 5 study visits including the initial baseline visit were they will be randomized into one of the 2 groups (comparison or treatment). At the baseline visit the following will be collected; history of the patient, physical examination of the patient including:, digital imaging of the diabetic foot ulcer (DFU) or chronic wound that is input into the WoundMatrix™ software, and the patient will be asked to complete a quality of life questionnaire. Patients will be provided with education regarding diabetes, footwear, and wound care. They will also be given a diary to log their treatments. Patients will return for study visits 2-5 on weeks 4, 8, 12, 16. At study visit 2-5 the research staff will collect digital imaging of the ulcer, review medication, collect previous diary and distribute a new one, and note any wound or health complications. At study visits 1 and 5, the patient will be asked to complete the quality of life questionnaire. These visits will be correlated with their regular scheduled visit at the CWC. If their wound heals before the end of the study, they will be asked to return for study visit 5 (week 16). The patient will complete the at home treatments, including the 90 minute treatment, 4 consecutive days a week, 3 day of no treatment). Study personnel will provide supplies, teach, and give support for the TO device. The study personnel will contact the subject weekly to give support for the treatments.
Participation in this study is expected to add no additional risk to the patient. There is a low risk of local irritation of the skin from application of the Topical Oxygen device for those in the Topical Oxygen Therapy group. This issue is anticipated in the protocol, which specifies appropriate treatment modifications and discontinuation of Topical Oxygen, if it does not improve. If this problem occurs, is expected to be self-limited and of minor significance. Oxygen, although not combustible itself, supports combustion of other flammable materials. The use of oxygen in this protocol is essentially equivalent to that supplied by nasal cannula to patients in hospital or at home. To minimize the risk of fire, the investigators will strictly enforce a 'no smoking' and 'no open flame' policy in any room where Topical Oxygen is utilized. Treatment facilities will comply with local fire ordinances and study personnel will be familiar with fire safety protocols of each facility.
Participants may or may not experience directly benefit from participating in this study. The disease state is highly morbid and typically involves prolonged medical care and multiple surgical procedures. Participants may experience improved healing of their wound as a result of their participation in this study, but there is no guarantee of this. Patients enrolled in the study may also benefit from the close follow-up with study staff and compliance with wound treatment. In addition, the information learned from this research study may lead to a better understanding of diabetic wounds and how they heal, which could lead to better treatment options for patients with diabetic wounds in the future. The application of topical oxygen to diabetic wounds has the potential to dramatically impact the effectiveness of wound healing and to therefore improve limb salvage, decrease infection rates and mortality, and generally improve the quality of life of study participants receiving topical oxygen as well as the general population if efficacy is proved.
- Conditions
- Diabetic Foot Ulcers, Wound
- Being tested
- Topical Oxygen Chamber for Extremities
- Keywords
- Diabetic Foot Ulcer, Topical Oxygen Therapy, Medicaid Recipients, Standard of Care, Diabetic Wounds
- Medical subject headings
- Diabetic Foot, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Oxygen Chamber for ExtremitiesDevice
Also called Topical Oxygen Device
Surrounds a limb and applies oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care with Topical Oxygen Treatment | Experimental | patients who have a chronic wound, will receive their receive standard treatment plus Topical Oxygen Therapy (Topical Oxygen Chamber for Extremities). Receives: Device: Topical Oxygen Chamber for Extremities |
| Standard of Care only | No intervention | patients that have a chronic wound will receive only their standard of care treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wound Closure
Wound healing rates at 16 weeks of Topical Oxygen Therapy or Standard of Care
Measured: baseline and 16 weeks
Secondary outcomes (4)
Rate of Amputations
Amputations rates 16 weeks of Topical Oxygen Therapy or Standard of Care
Measured: 16 weeks
Complication Rate
Complication rates (infection) at 16 weeks of Topical Oxygen Therapy or Standard of Care
Measured: 16 weeks
Cost of Care
Post-test health expenditures at 16 weeks of Topical Oxygen Therapy or Standard of Care
Measured: 16 weeks
Quality of Life for Subjects- SF-36
QoL data at 16 weeks of Topical Oxygen Therapy or Standard of Care. A cumulative score was calculated based on the QoL responses:
Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study start1 Feb 2020
- Primary completion5 Aug 2021
- Study completion5 Aug 2021
Why it stopped: Recruitment unfulfilled due to lack of staffing.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chandan Sen, Indiana University
- Investigators
- Chandan K. Sen, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313428
- Sponsor's protocol ID
- 1905092117
- Status last verified
- Apr 2024
- First submitted
- 8 Dec 2014
- Last updated
- 25 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Fischer BH. Topical hyperbaric oxygen treatment of pressure sores and skin ulcers. Lancet. 1969 Aug 23;2(7617):405-9. doi: 10.1016/s0140-6736(69)90113-5. No abstract available.
PubMed 4184490Gordillo GM, Roy S, Khanna S, Schlanger R, Khandelwal S, Phillips G, Sen CK. Topical oxygen therapy induces vascular endothelial growth factor expression and improves closure of clinically presented chronic wounds. Clin Exp Pharmacol Physiol. 2008 Aug;35(8):957-64. doi: 10.1111/j.1440-1681.2008.04934.x. Epub 2008 Apr 21.
PubMed 18430064Heng MCY, Pilgrim JP and Beck FWJ. A simplified technique for hyperbaric oxygen administration for leg ulcers. Clin Res 1982, 30:262A.
Heng MC, Pilgrim JP, Beck FW. A simplified hyperbaric oxygen technique for leg ulcers. Arch Dermatol. 1984 May;120(5):640-5.
PubMed 6721526Kalliainen LK, Gordillo GM, Schlanger R, Sen CK. Topical oxygen as an adjunct to wound healing: a clinical case series. Pathophysiology. 2003 Jan;9(2):81-87. doi: 10.1016/s0928-4680(02)00079-2.
PubMed 14567939Proposed Rule -General and Plastic Surgery Devices; General Provisions and Classification of 54 Devices, 47 Fed. Reg. 2810-2853 (Jan. 19, 1982).
Final Rule -General and Plastic Surgery Devices; General Provisions and Classification of 51 Devices, 53 Fed. Reg. 23856, 23869-23870 (June 24, 1988).
Food and Drug Administration, HHS. Medical devices; reclassification of the topical oxygen chamber for extremities. Final rule. Fed Regist. 2011 Apr 25;76(79):22805-7.
PubMed 21516875Heng MC, Harker J, Bardakjian VB, Ayvazian H. Enhanced healing and cost-effectiveness of low-pressure oxygen therapy in healing necrotic wounds: a feasibility study of technology transfer. Ostomy Wound Manage. 2000 Mar;46(3):52-60, 62.
PubMed 10788918Heng MC, Harker J, Csathy G, Marshall C, Brazier J, Sumampong S, Paterno Gomez E. Angiogenesis in necrotic ulcers treated with hyperbaric oxygen. Ostomy Wound Manage. 2000 Sep;46(9):18-28, 30-2.
PubMed 11189538Ware, J.E., Snow, K.K., Kolinski, M., Gandeck, B., 1993. SF-36 Health survey manual and interpretation guide. The Health Institute, New England Medical Centre, Boston, MA.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Topical Oxygen for Diabetic Wounds
- ClinicalTrials.gov ID
- NCT02313428
- Acronym / sponsor ID
- 1905092117
- Conditions
- Diabetic Foot Ulcers, Wound
- Keywords
- Diabetic Foot Ulcer, Topical Oxygen Therapy, Medicaid Recipients, Standard of Care, Diabetic Wounds
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment unfulfilled due to lack of staffing.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 10 Dec 2014 (estimated)
- Results
- Posted 25 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study which is intended to collect data to calculate an adequate sample size for a larger registered clinical trial. Eleven subjects were enrolled at The Ohio State University; we intend to enroll 29 more subjects at Indiana University. Due to the small sample size this study will primarily be a feasibility study that will attempt to measure and evaluate differences in the relative theoretical costs of the intervention of topical oxygen therapy on this population and subsequently compare outcomes in areas such as overall health improvements and cost effectiveness.
Detailed description
There are a total of 5 study visits including the initial baseline visit were they will be randomized into one of the 2 groups (comparison or treatment). At the baseline visit the following will be collected; history of the patient, physical examination of the patient including:, digital imaging of the diabetic foot ulcer (DFU) or chronic wound that is input into the WoundMatrix™ software, and the patient will be asked to complete a quality of life questionnaire. Patients will be provided with education regarding diabetes, footwear, and wound care. They will also be given a diary to log their treatments. Patients will return for study visits 2-5 on weeks 4, 8, 12, 16. At study visit 2-5 the research staff will collect digital imaging of the ulcer, review medication, collect previous diary and distribute a new one, and note any wound or health complications. At study visits 1 and 5, the patient will be asked to complete the quality of life questionnaire. These visits will be correlated with their regular scheduled visit at the CWC. If their wound heals before the end of the study, they will be asked to return for study visit 5 (week 16). The patient will complete the at home treatments, including the 90 minute treatment, 4 consecutive days a week, 3 day of no treatment). Study personnel will provide supplies, teach, and give support for the TO device. The study personnel will contact the subject weekly to give support for the treatments.
Participation in this study is expected to add no additional risk to the patient. There is a low risk of local irritation of the skin from application of the Topical Oxygen device for those in the Topical Oxygen Therapy group. This issue is anticipated in the protocol, which specifies appropriate treatment modifications and discontinuation of Topical Oxygen, if it does not improve. If this problem occurs, is expected to be self-limited and of minor significance. Oxygen, although not combustible itself, supports combustion of other flammable materials. The use of oxygen in this protocol is essentially equivalent to that supplied by nasal cannula to patients in hospital or at home. To minimize the risk of fire, the investigators will strictly enforce a 'no smoking' and 'no open flame' policy in any room where Topical Oxygen is utilized. Treatment facilities will comply with local fire ordinances and study personnel will be familiar with fire safety protocols of each facility.
Participants may or may not experience directly benefit from participating in this study. The disease state is highly morbid and typically involves prolonged medical care and multiple surgical procedures. Participants may experience improved healing of their wound as a result of their participation in this study, but there is no guarantee of this. Patients enrolled in the study may also benefit from the close follow-up with study staff and compliance with wound treatment. In addition, the information learned from this research study may lead to a better understanding of diabetic wounds and how they heal, which could lead to better treatment options for patients with diabetic wounds in the future. The application of topical oxygen to diabetic wounds has the potential to dramatically impact the effectiveness of wound healing and to therefore improve limb salvage, decrease infection rates and mortality, and generally improve the quality of life of study participants receiving topical oxygen as well as the general population if efficacy is proved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care with Topical Oxygen Treatment | Experimental | Device: Topical Oxygen Chamber for Extremitiespatients who have a chronic wound, will receive their receive standard treatment plus Topical Oxygen Therapy (Topical Oxygen Chamber for Extremities). |
| Standard of Care only | No intervention | –patients that have a chronic wound will receive only their standard of care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age >18 years
- Able to give informed consent, willing and able to visit the hospital and CWC for regular treatment and follow-up visits.
- Diabetic
- -Chronic wound OR Foot Ulcer:
- Ulcer present by history ≥ 4 weeks at time of enrollment
Key exclusion criteria (8 listed)
- Ulcer in area of radiation treatment.
- Active malignancy at site of ulcer
- Current treatment with wound VAC or weekly compression dressing
- Untreated infection at site of ulcer (i.e. cellulitis or osteomyelitis)
- If acute osteomyelitis has been diagnosed, patient may be enrolled only after the infection has been controlled. Including:
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 |
|---|---|---|
| Topical Oxygen Chamber for ExtremitiesAlso: Topical Oxygen DeviceSurrounds a limb and applies oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers | Device | Standard of Care with Topical Oxygen Treatment |
Primary outcome
Change in Wound Closure
Time frame: baseline and 16 weeks
Wound healing rates at 16 weeks of Topical Oxygen Therapy or Standard of Care
4 secondary outcomes
Rate of Amputations
Time frame: 16 weeks
Complication Rate
Time frame: 16 weeks
Cost of Care
Time frame: 16 weeks
Quality of Life for Subjects- SF-36
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 4184490Fischer BH. Topical hyperbaric oxygen treatment of pressure sores and skin ulcers. Lancet. 1969 Aug 23;2(7617):405-9. doi: 10.1016/s0140-6736(69)90113-5. No abstract available.
- Background: PubMed 18430064Gordillo GM, Roy S, Khanna S, Schlanger R, Khandelwal S, Phillips G, Sen CK. Topical oxygen therapy induces vascular endothelial growth factor expression and improves closure of clinically presented chronic wounds. Clin Exp Pharmacol Physiol. 2008 Aug;35(8):957-64. doi: 10.1111/j.1440-1681.2008.04934.x. Epub 2008 Apr 21.
- BackgroundHeng MCY, Pilgrim JP and Beck FWJ. A simplified technique for hyperbaric oxygen administration for leg ulcers. Clin Res 1982, 30:262A.
- Background: PubMed 6721526Heng MC, Pilgrim JP, Beck FW. A simplified hyperbaric oxygen technique for leg ulcers. Arch Dermatol. 1984 May;120(5):640-5.
- Background: PubMed 14567939Kalliainen LK, Gordillo GM, Schlanger R, Sen CK. Topical oxygen as an adjunct to wound healing: a clinical case series. Pathophysiology. 2003 Jan;9(2):81-87. doi: 10.1016/s0928-4680(02)00079-2.
- BackgroundProposed Rule -General and Plastic Surgery Devices; General Provisions and Classification of 54 Devices, 47 Fed. Reg. 2810-2853 (Jan. 19, 1982).
- BackgroundFinal Rule -General and Plastic Surgery Devices; General Provisions and Classification of 51 Devices, 53 Fed. Reg. 23856, 23869-23870 (June 24, 1988).
- Background: PubMed 21516875Food and Drug Administration, HHS. Medical devices; reclassification of the topical oxygen chamber for extremities. Final rule. Fed Regist. 2011 Apr 25;76(79):22805-7.
- Background: PubMed 10788918Heng MC, Harker J, Bardakjian VB, Ayvazian H. Enhanced healing and cost-effectiveness of low-pressure oxygen therapy in healing necrotic wounds: a feasibility study of technology transfer. Ostomy Wound Manage. 2000 Mar;46(3):52-60, 62.
- Background: PubMed 11189538Heng MC, Harker J, Csathy G, Marshall C, Brazier J, Sumampong S, Paterno Gomez E. Angiogenesis in necrotic ulcers treated with hyperbaric oxygen. Ostomy Wound Manage. 2000 Sep;46(9):18-28, 30-2.
- BackgroundWare, J.E., Snow, K.K., Kolinski, M., Gandeck, B., 1993. SF-36 Health survey manual and interpretation guide. The Health Institute, New England Medical Centre, Boston, MA.
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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.
Chandan K. Sen, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Oxygen Chamber for Extremities in people with Diabetic Foot Ulcers and Wound, run by Indiana University at 1 site in United States.
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 15 inclusion and 8 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: stopped early, as of the sponsor's last update on 25 Apr 2024. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Wound Closure (time frame: baseline and 16 weeks). 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 NCT02313428, which also lists 11 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 25 Apr 2024.