Trial Outcomes & Findings for Continuous Diffusion of Oxygen (CDO) Treatment for Healing of Diabetic Foot Ulcers (NCT NCT02501538)

NCT ID: NCT02501538

Last Updated: 2023-07-24

Results Overview

Hyperspectral (HyperMed, Inc.) images were taken for evaluation of tissue oxygenation following debridement at Visit 1 (day 0), visit 2 (day 7), visit 3 (day 14), visit 4 (day 21). Two images were taken of the study foot - one of the plantar surface and one of the dorsal surface to evaluate the oxygenation of the entire foot. Measurements of oxygenated hemoglobin are generated by the camera for each image. Results are reported in aggregate as mean/standard error for all time points.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

21 days

Results posted on

2023-07-24

Participant Flow

Participant milestones

Participant milestones
Measure
Transcutaneous O2 Device
Continuous diffusion of oxygen (CDO) (topical oxygen) therapy, which will be administered using a portable device. Transcutaneous O2 device: A portable device that delivers continuous diffusion of oxygen.
Overall Study
STARTED
23
Overall Study
COMPLETED
20
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Diffusion of Oxygen (CDO) Treatment for Healing of Diabetic Foot Ulcers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Transcutaneous O2 Device
n=23 Participants
Continuous diffusion of oxygen (CDO) (topical oxygen) therapy, which will be administered using a portable device. Transcutaneous O2 device: A portable device that delivers continuous diffusion of oxygen.
Age, Categorical
<=18 years
0 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
n=93 Participants
Age, Categorical
>=65 years
3 Participants
n=93 Participants
Sex: Female, Male
Female
8 Participants
n=93 Participants
Sex: Female, Male
Male
15 Participants
n=93 Participants
Race/Ethnicity, Customized
Caucasian
11 Participants
n=93 Participants
Race/Ethnicity, Customized
African American
5 Participants
n=93 Participants
Race/Ethnicity, Customized
Hispanic
7 Participants
n=93 Participants

PRIMARY outcome

Timeframe: 21 days

Population: There was no control arm for this study. For analysis, groups were analyzed as "healer" and "nonhealer." Healers are defined by those patients who achieved a 50% wound area reduction in the study time frame and are likely to heal within 12 weeks. Nonhealers did not reach a 50% wound area reduction in the study time frame.

Hyperspectral (HyperMed, Inc.) images were taken for evaluation of tissue oxygenation following debridement at Visit 1 (day 0), visit 2 (day 7), visit 3 (day 14), visit 4 (day 21). Two images were taken of the study foot - one of the plantar surface and one of the dorsal surface to evaluate the oxygenation of the entire foot. Measurements of oxygenated hemoglobin are generated by the camera for each image. Results are reported in aggregate as mean/standard error for all time points.

Outcome measures

Outcome measures
Measure
Transcutaneous O2 Device
n=23 Participants
Continuous diffusion of oxygen (CDO) (topical oxygen) therapy, which will be administered using a portable device. Transcutaneous O2 device: A portable device that delivers continuous diffusion of oxygen.
Tissue Oxygenation as Measured by Hyperspectral Imaging
Dorsal oxyhemoglobin - healer
63.58 percent concentration of oxyhemoglobin
Standard Error 11.17
Tissue Oxygenation as Measured by Hyperspectral Imaging
Dorsal oxyhemoglobin - nonhealer
61.91 percent concentration of oxyhemoglobin
Standard Error 9.14
Tissue Oxygenation as Measured by Hyperspectral Imaging
Plantar oxyhemoglobin - healer
76.33 percent concentration of oxyhemoglobin
Standard Error 4.86
Tissue Oxygenation as Measured by Hyperspectral Imaging
Plantar oxyhemoglobin - nonhealer
77.55 percent concentration of oxyhemoglobin
Standard Error 5.90

PRIMARY outcome

Timeframe: 21 days

Population: There was no control arm for this study. For analysis, groups were analyzed as "healer" and "nonhealer." Healers are defined by those patients who achieved a 50% wound area reduction in the study time frame and are likely to heal within 12 weeks. Nonhealers did not reach a 50% wound area reduction in the study time frame

Transcutaneous oxygen pressure (TCPO2) was measured at visit 1 (day 0), visit 2 (day 7), visit 3 (day 14), visit 4 (day 21) to assess perfusion of the tissue. This is measured at the medial and lateral foot to include both major blood vessels to the foot. Reported here as aggregate mean over all time points.

Outcome measures

Outcome measures
Measure
Transcutaneous O2 Device
n=23 Participants
Continuous diffusion of oxygen (CDO) (topical oxygen) therapy, which will be administered using a portable device. Transcutaneous O2 device: A portable device that delivers continuous diffusion of oxygen.
Tissue Perfusion as Measured by TCPO2
Transcutaneous oxygen - medial foot - healer
53.31 mmHg
Standard Error 4.33
Tissue Perfusion as Measured by TCPO2
Transcutaneous oxygen - medial foot - nonhealer
53.64 mmHg
Standard Error 3.97
Tissue Perfusion as Measured by TCPO2
Transcutaneous oxygen - lateral foot - healer
55.21 mmHg
Standard Error 3.46
Tissue Perfusion as Measured by TCPO2
Transcutaneous oxygen - lateral foot - nonhealer
59.31 mmHg
Standard Error 4.68

SECONDARY outcome

Timeframe: 21 days

Comparison of measurements inflammatory cytokines: Interleukin 6 (IL-6), Interleukin 8 (IL-8), tumor necrosis factor (TNF)-α and growth factors: vascular endothelial growth factor (VEGF), platelet derived growth factor (PDGF), insulin derived growth factor (IGF), transforming growth factor beta (TGF)-β. These are reported as log fold change by delta delta ct. Evaluated from tissue samples obtained at visit 1 (day 0), visit 2 (day 7), visit 3 (day 14), visit 4 (day 21).

Outcome measures

Outcome measures
Measure
Transcutaneous O2 Device
n=23 Participants
Continuous diffusion of oxygen (CDO) (topical oxygen) therapy, which will be administered using a portable device. Transcutaneous O2 device: A portable device that delivers continuous diffusion of oxygen.
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
IL8 visit 1
3.97 log fold change
Standard Error 1.90
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
VEGF visit 2
5.85 log fold change
Standard Error 1.40
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
VEGF visit 3
4.35 log fold change
Standard Error 1.42
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
VEGF visit 4
3.29 log fold change
Standard Error 0.99
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
PDGF visit 1
1.40 log fold change
Standard Error 0.23
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
IL-6 Visit 2
11.37 log fold change
Standard Error 5.11
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
IL8 visit 2
3.12 log fold change
Standard Error 1.31
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
IL8 visit 3
7.51 log fold change
Standard Error 2.89
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
IL8 visit 4
5.22 log fold change
Standard Error 2.38
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
TNFa visit 1
1.82 log fold change
Standard Error 0.41
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
TNFa visit 2
8.17 log fold change
Standard Error 2.26
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
TNFa visit 3
5.03 log fold change
Standard Error 1.73
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
TNFa visit 4
3.27 log fold change
Standard Error 1.19
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
VEGF visit 1
1.37 log fold change
Standard Error 0.26
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
PDGF visit 2
3.92 log fold change
Standard Error 1.31
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
PDGF visit 3
1.76 log fold change
Standard Error 0.37
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
PDGF visit 4
1.81 log fold change
Standard Error 0.52
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
IGF1 visit 1
3.04 log fold change
Standard Error 1.18
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
IGF1 visit 2
19.91 log fold change
Standard Error 9.10
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
IGF1 visit 3
5.47 log fold change
Standard Error 2.46
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
IGF1 visit 4
5.25 log fold change
Standard Error 2.0
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
TGFb visit 1
1.27 log fold change
Standard Error 0.19
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
TGFb visit 2
10.42 log fold change
Standard Error 3.05
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
TGFb visit 3
4.65 log fold change
Standard Error 1.22
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
TGFb visit 4
3.96 log fold change
Standard Error 1.26
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
IL-6 visit 1
2.68 log fold change
Standard Error 0.82
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
IL-6 Visit 3
18.24 log fold change
Standard Error 6.48
Change in Levels of Growth Factors and Cytokines Involved in Wound Healing
IL-6 Visit 4
9.12 log fold change
Standard Error 2.53

SECONDARY outcome

Timeframe: 21 days

Tissue samples sent for 16s rRNA quantitative culture. Reported in aggregate for each visit that corresponds to Visit 1 (day 0), visit 2 (day 7), visit 3 (day 14), visit 4 (day 21).

Outcome measures

Outcome measures
Measure
Transcutaneous O2 Device
n=23 Participants
Continuous diffusion of oxygen (CDO) (topical oxygen) therapy, which will be administered using a portable device. Transcutaneous O2 device: A portable device that delivers continuous diffusion of oxygen.
Evaluate Changes in Bacterial Infection
Visit 1
137071.35 CFU/ml
Standard Deviation 204854.93
Evaluate Changes in Bacterial Infection
Visit 2
433719.88 CFU/ml
Standard Deviation 1009663.23
Evaluate Changes in Bacterial Infection
Visit 3
276842.20 CFU/ml
Standard Deviation 603627.08
Evaluate Changes in Bacterial Infection
Visit 4
598557.90 CFU/ml
Standard Deviation 2303848.45

SECONDARY outcome

Timeframe: 21 days

Population: There was no control arm for this study. For analysis, groups were analyzed as "healer" and "nonhealer." Healers are defined by those patients who achieved a 50% wound area reduction in the study time frame and are likely to heal within 12 weeks. Nonhealers did not reach a 50% wound area reduction in the study time frame.

Percent change of the wound area (measured in cm\^2) of visit 2 (day 7), visit 3 (day 14), and visit 4 (day 21) compared to baseline. Percent area reduction = initial surface area (length in cm x width in cm) minus current surface area (length in cm x width in cm), divided by initial surface area. multiplied by 100 to get percentage.

Outcome measures

Outcome measures
Measure
Transcutaneous O2 Device
n=23 Participants
Continuous diffusion of oxygen (CDO) (topical oxygen) therapy, which will be administered using a portable device. Transcutaneous O2 device: A portable device that delivers continuous diffusion of oxygen.
Percent Wound Area Reduction
Wound area reduction - visit 1 - healers
40.75 percent change of wound area (cm^2)
Standard Error 8.26
Percent Wound Area Reduction
Wound area reduction - visit 3 - healers
48.64 percent change of wound area (cm^2)
Standard Error 6.82
Percent Wound Area Reduction
Wound area reduction - visits 4 - healers
59.91 percent change of wound area (cm^2)
Standard Error 7.55
Percent Wound Area Reduction
Wound area reduction - visit 2 - nonhealers
7.59 percent change of wound area (cm^2)
Standard Error 6.32
Percent Wound Area Reduction
Wound area reduction - visit 3 - nonhealers
-30.07 percent change of wound area (cm^2)
Standard Error 17.25
Percent Wound Area Reduction
ound area reduction- visit 4 - nonhealers
-11.21 percent change of wound area (cm^2)
Standard Error 14.50

Adverse Events

Transcutaneous O2 Device

Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Transcutaneous O2 Device
n=23 participants at risk
Continuous diffusion of oxygen (CDO) (topical oxygen) therapy, which will be administered using a portable device. Transcutaneous O2 device: A portable device that delivers continuous diffusion of oxygen.
Skin and subcutaneous tissue disorders
Celluliltis
4.3%
1/23 • 21 days

Other adverse events

Other adverse events
Measure
Transcutaneous O2 Device
n=23 participants at risk
Continuous diffusion of oxygen (CDO) (topical oxygen) therapy, which will be administered using a portable device. Transcutaneous O2 device: A portable device that delivers continuous diffusion of oxygen.
Skin and subcutaneous tissue disorders
Abrasion
4.3%
1/23 • 21 days
Skin and subcutaneous tissue disorders
Foot swelling
4.3%
1/23 • 21 days

Additional Information

Lawrence Lavery, DPM, MPH

UT Southwestern Medical Center at Dallas

Phone: 214-645-0544

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place