Trial Outcomes & Findings for Spinal Cord Stimulation for Painful Diabetic Neuropathy (NCT NCT00487981)

NCT ID: NCT00487981

Last Updated: 2012-03-13

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

6 months

Results posted on

2012-03-13

Participant Flow

Participant milestones

Participant milestones
Measure
Spinal Cord Stimulation (SCS) Group
Spinal Cord Stimulation (SCS) Treatment Group
Overall Study
STARTED
1
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Spinal Cord Stimulation (SCS) Group
Spinal Cord Stimulation (SCS) Treatment Group
Overall Study
Hypothyroidism diagnosis
1

Baseline Characteristics

Spinal Cord Stimulation for Painful Diabetic Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Spinal Cord Stimulation (SCS) Group
n=1 Participants
Spinal Cord Stimulation (SCS) Treatment Group
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=99 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
Age Continuous
59 years
STANDARD_DEVIATION 0 • n=99 Participants
Sex: Female, Male
Female
1 Participants
n=99 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
Region of Enrollment
United States
1 participants
n=99 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

Adverse Events

Spinal Cord Stimulation (SCS) Group

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

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lyn M. Pimentel, M.B.A.

Boston Scientific

Phone: (661) 949-4174

Results disclosure agreements

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

Restriction type: LTE60