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Trial registered on ANZCTR

Registration number

ACTRN12617001164381

Ethics application status

Approved

Date submitted

29/06/2017

Date registered

8/08/2017

Date last updated

14/01/2021

Date data sharing statement initially provided

26/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Use of Procalcitonin in Diagnosing and Monitoring Diabetic Foot Osteomyelitis and Cellulitis at The Townsville Hospital–A Pilot Study

Scientific title

Use of Procalcitonin in Diagnosing and Monitoring Diabetic Foot Osteomyelitis and Cellulitis at The Townsville Hospital–A Pilot Study

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes

Diabetic Foot infections

Foot Ulcer

Condition category

Condition code

Infection

Other infectious diseases

Metabolic and Endocrine

Diabetes

Skin

Other skin conditions

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Diabetic foot cellulitis will be confirmed histologically through tissue biopsy/debridement (group 1 = 25). Serum procalcitonin levels will be determined using a commercially available enzyme-linked fluorescent assay and will be compared with the histology report as a diagnostic marker at onset of the study and at week 6 and 12 to monitor response to the usual care. Subjects will receive the treatment fortnightly comprising the following as usual care: After debridement, atraumatic dressing and nonadherent absorbent pad will be applied. Antibiotics will be administered based on microscopy, culture, and sensitivity results following deep wound swab and blood cultures. No additional treatment will be offered apart from the usual care.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

Diabetic foot osteomyelitis will be confirmed histologically through tissue biopsy/debridement (group 2 = 25). Serum procalcitonin levels will be determined using a commercially available enzyme-linked fluorescent assay and will be compared with the histology report as a diagnostic marker at onset of the study and at week 6 and 12 to monitor response to the usual care. Subjects will receive the treatment fortnightly comprising the following as usual care: after debridement, atraumatic dressing and nonadherent absorbent pad will be applied. Antibiotics will be administered based on microscopy, culture, and sensitivity results following deep wound swab and blood cultures. No additional treatment will be offered apart from the usual care.

Control group

Active

Outcomes

Primary outcome [1]

The serum procalcitonin levels of the patients at week 1 will be computed to determine the most suitable discriminating concentrations to diagnose diabetic foot cellulitis and osteomyelitis based on the gold-standard histologic diagnosis.

Timepoint [1]

For diagnostic purpose only week 1 (baseline) serum levels will be used.

Primary outcome [2]

Determining serum procalcitonin levels to monitor treatment response of diabetic foot cellulitis and osteomyelitis from week 1 to 12...

Timepoint [2]

For monitoring response to treatment of diabetic foot cellulitis and osteomyelitis serum procalcitonin levels at week 1, 6 and 12 will be analysed.

Secondary outcome [1]

Cost-effectiveness of using serum procalcitonin in diagnosing diabetic foot cellulitis and osteomyelitis will be expressed as an incremental cost effectiveness ratio and results will be presented in cost effectiveness planes as well as cost-effectiveness acceptability curves. The data will be linked and compared with the hospital cost records.

Timepoint [1]

Cost-effectiveness of using serum procalcitonin in monitoring diabetic foot cellulitis and osteomyelitis response to treatment at week 1, 6 and 12.

Eligibility

Key inclusion criteria

Patients meeting the following inclusion criteria will be eligible to enter the study:
1. Subjects with diabetic foot ulcer
2. Aged 18 years or over
3. Exclusion of other etiologies of foot ulcer.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients meeting any of the following criteria will not be included in the study:

1. Clinical infection at the studied ulcer site (bacterial and fungal)
2. Planned surgical intervention for the diabetic foot ulcer
3. Clinically significant lower-extremity ischemia (as defined by an ankle/brachial index of <0.65)
4. Significant medical conditions that would impair wound healing will also be excluded from the study. These conditions include hepatic, respiratory or cardiac failures, aplastic anemia, scleroderma and malignancy, treatment with immunosuppressive agents or steroids, myocardial infarcts, stroke, major surgery within 6 months of the study, or usage of tobacco
5. Ulcer of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis-related ulcers, calciphylaxis or dystrophic calcinosis cutis)
6. Active malignancy other than basal cell carcinoma as well as subjects with cancerous or pre-cancerous lesions in the ulcer area
7. Pregnancy
8. Inability to comply with study protocol

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Statistical analysis will be performed using the SAS 9.4 statistical package. Differences between the two groups will be tested using parametric or nonparametric methods according to the specific indications. Differences between the laboratory levels of the two groups at baseline will be measured using the Wilcoxon rank sum test in median. Data will be presented as mean +/standard deviation. In addition, analysis of variance for repeated measurements will be performed to test the timing effect of the studied parameters in the follow-up of the patients. The same analysis will be used to examine for differences during follow-up between patients with diabetic foot cellulitis and diabetic foot osteomyelitis. The Greenhouse–Geisser adjustment will be used when the sphericity assumptions are not fulfilled. P values <0.05 will be considered statistically significant.

Cost effectiveness of procalcitonin test will be expressed as an Incremental Cost Effectiveness Ratio (ICER), which will be calculated as incremental costs divided by incremental effects. The results will be presented in cost-effectiveness planes and cost-effectiveness acceptability curves (CEACs). Furthermore, prospective cost savings from use of procalcitonin monitoring foot ulcer healing of the 2 conditions will be conducted using a one-way sensitivity analysis to test the robustness of findings in net savings.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/09/2017

Actual

1/11/2017

Date of last participant enrolment

Anticipated

31/05/2022

Actual

Date of last data collection

Anticipated

31/08/2022

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Townsville Hospital - Douglas

Recruitment postcode(s) [1]

4814 - Douglas

Funding & Sponsors

Funding source category [1]

University

Name [1]

James Cook University

Address [1]

Translational Research in Endocrinology and Diabetes [TREAD]
1, James Cook Drive
Douglas, QLD 4811

Country [1]

Australia

Primary sponsor type

University

Name

James Cook University

Address

Translational Research in Endocrinology and Diabetes [TREAD]
1 James Cook Drive
Douglas QLD 4811

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

The Townsville Hospital

Address [1]

100 Angus Smith Drive, Douglas QLD 4814

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Townsville Hospital and Health Services

Ethics committee address [1]

100 Angus Smith Drive, Douglas QLD 4814.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/06/2017

Approval date [1]

31/10/2017

Ethics approval number [1]

31/10/2017

Summary

Brief summary

Diabetic foot bone infection (osteomyelitis) is among the most common causes of leg amputation and prolonged hospitalization among Australians. Early and prompt diagnosis and treatment of osteomyelitis is crucial to reducing hospital admissions and limb amputations. Currently the tests that are used to confirm osteomyelitis are either costly (MRI, bone scan), not readily available at the time of immediate need (MRI) or ineffective (x-ray) in differentiating foot osteomyelitis from soft tissue foot infections (cellulitis). To date no simple laboratory test shown to reliably differentiate the 2 common form of diabetic foot infections –cellulitis and osteomyelitis. 

Procalcitonin, a cheap, simple blood test for detecting and monitoring infections in other conditions is thought to be a useful test for diabetic foot infections. Blood level of procalcitonin has been reported to be markedly elevated in bone infections and lower levels in cellulitis. This study is designed to determine the role of procalcitonin in correctly distinguishing diabetic foot cellulitis from osteomyelitis and to assess levels that will be used to monitor response to treatment of both conditions.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof usman H. Malabu

Address

The Townsville Hospital
100 Angus Smith Drive
Douglas
QLD 4814.

Country

Australia

Phone

+61-7-4433 1111

Fax

[email protected]

Contact person for public queries

Name

Usman H. Malabu

Address

The Townsville Hospital
100 Angus Smith Drive
Douglas
QLD 4814.

Country

Australia

Phone

+61-7-4433 1111

Fax

[email protected]

Contact person for scientific queries

Name

Usman H. Malabu

Address

The Townsville Hospital
100 Angus Smith Drive
Douglas
QLD 4814.

Country

Australia

Phone

+61-7-4433 1111

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Study not yet completed

What supporting documents are/will be available?

Doc. No.	Type	Email
4255	Study protocol	[email protected]
4256	Statistical analysis plan	[email protected]
4257	Informed consent form	[email protected]
4258	Ethical approval	[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically