Trial Outcomes & Findings for Neurogenic Inflammation in Diabetes (NCT NCT01370837)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

48 hours after injection.

Results posted on

2015-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Controls Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot. Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer.	Diabetes Patients with diabetes mellitus without polyneuropathy. Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot. Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer.	Polyneuropathy Patients with diabetes and polyneuropathy. Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot. Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer.
Overall Study STARTED	12	12	17
Overall Study COMPLETED	12	12	17
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neurogenic Inflammation in Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Controls n=12 Participants Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot. Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer.	Diabetes n=12 Participants Patients with diabetes mellitus without polyneuropathy. Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot. Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer.	Polyneuropathy n=17 Participants Patients with diabetes and polyneuropathy. Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot. Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer.	Total n=41 Participants Total of all reporting groups
Age, Continuous	59 years STANDARD_DEVIATION 8.8 • n=5 Participants	65 years STANDARD_DEVIATION 6.7 • n=7 Participants	66 years STANDARD_DEVIATION 5.2 • n=5 Participants	64 years STANDARD_DEVIATION 7.3 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants	32 Participants n=4 Participants
Region of Enrollment Netherlands	12 participants n=5 Participants	12 participants n=7 Participants	17 participants n=5 Participants	41 participants n=4 Participants

PRIMARY outcome

Timeframe: 48 hours after injection.

Outcome measures

Outcome measures
Measure	Healthy Controls n=12 Participants Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot. Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer.	Diabetes n=12 Participants Patients with diabetes mellitus without polyneuropathy. Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot. Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer.	Polyneuropathy n=17 Participants Patients with diabetes and polyneuropathy. Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot. Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer.
Induration Size as a Response to Intracutaneous Candida Albicans. Arm	4 millimeters Interval 1.0 to 13.5	6 millimeters Interval 1.5 to 11.0	5 millimeters Interval 2.0 to 6.0
Induration Size as a Response to Intracutaneous Candida Albicans. Foot	4 millimeters Interval 0.0 to 9.0	2 millimeters Interval 0.0 to 11.5	0 millimeters Interval 0.0 to 1.0

Adverse Events

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diabetes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Polyneuropathy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Healthy Controls n=12 participants at risk Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot. Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer.	Diabetes n=12 participants at risk Patients with diabetes mellitus without polyneuropathy. Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot. Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer.	Polyneuropathy n=17 participants at risk Patients with diabetes and polyneuropathy. Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot. Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer.
Skin and subcutaneous tissue disorders Allergic reaction to Candida antigen	0.00% 0/12	0.00% 0/12	5.9% 1/17

Other adverse events

Adverse event data not reported

Additional Information

Kristy Pickwell

Maastricht University Medical Center

Phone: +31433877019

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place