Trial Outcomes & Findings for Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain (NCT NCT03940963)

Last Updated: 2025-01-09

Results Overview

The Visual Analog Scale (VAS) For Pain is a patient reported outcomes scale whereby the patient indicates his/her current pain level by making a mark on a continuous horizontal 10-centimeter (100 millimeter) line. The distance from the 0 millimeter to the patient's mark corresponds to the amount of pain the participant is currently experiencing. VAS for Pain data are recorded as the number of millimeters from the left of the line to the patients mark across the range of 0-100 millimeters, with 0 millimeter representing "no pain" and 100 millimeters representing "the worst pain imaginable".

Recruitment status

COMPLETED

Study phase

Target enrollment

86 participants

Primary outcome timeframe

12 months

Results posted on

2025-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	AxoGuard® Nerve Cap Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
Overall Study STARTED	41	45
Overall Study COMPLETED	30	35
Overall Study NOT COMPLETED	11	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AxoGuard® Nerve Cap n=41 Participants Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=43 Participants Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).	Total n=84 Participants Total of all reporting groups
Age, Continuous	55.9 Years STANDARD_DEVIATION 11.1 • n=41 Participants	58.7 Years STANDARD_DEVIATION 12.8 • n=43 Participants	57.3 Years STANDARD_DEVIATION 12.0 • n=84 Participants
Sex: Female, Male Female	29 Participants n=41 Participants	34 Participants n=43 Participants	63 Participants n=84 Participants
Sex: Female, Male Male	12 Participants n=41 Participants	9 Participants n=43 Participants	21 Participants n=84 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	41 participants n=41 Participants	43 participants n=43 Participants	84 participants n=84 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Intent-to-treat (ITT) population, including all participants who were randomized, received the study device or underwent neurectomy, and completed at least one post-baseline assessment of efficacy. Analysis is based on treatment as randomized.

Outcome measures

Outcome measures
Measure	AxoGuard® Nerve Cap n=30 Participants Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=35 Participants Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
Change in Visual Analog Scale (VAS) For Pain Score at 12 Post-operative Months in Comparative Phase Subjects	-86.62 Millimeters (mm) Interval -95.21 to -78.03	-72.67 Millimeters (mm) Interval -81.02 to -64.32

PRIMARY outcome

Timeframe: 3 months

Population: This is the safety population (SP) which includes all participants who had the study device inserted or underwent neurectomy. Analysis is based on treatment as received.

The primary safety endpoint will compare the rate of SAEs related to the procedure or device between treatment groups. The rate of serious adverse events for a given timepoint is given as the number of participants with one or more events up to that timepoint out of the population at risk.

Outcome measures

Outcome measures
Measure	AxoGuard® Nerve Cap n=41 Participants Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=43 Participants Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 3 Months	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 3 months

Population: This is the safety population (SP) which includes all participants who had the study device inserted or underwent neurectomy. Analysis is based on treatment as received.

The primary safety endpoint will compare the rate of procedure- or device-related AEs or UADEs between treatment groups. The rate of events or effects for a given timepoint is given as the number of participants with one or more events up to that timepoint out of the population at risk.

Outcome measures

Outcome measures
Measure	AxoGuard® Nerve Cap n=41 Participants Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=43 Participants Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 3 Months	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Modified intent-to-treat (mITT) population, participants that completed at least one post-baseline assessment of efficacy. Analysis is based on the treatment as received.

The Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures is a set of person-centered measures that evaluates and monitors a patient's physical health and pain. The PROMIS - pain related measures include domains evaluating fatigue, pain intensity, paint interference, sleep Disturbance, and Pain Behavior. Short forms containing fixed sets of 4-10 items or questions are included for each domain. All PROMIS scores are presented as T-scores where the T-score is the standardized score with a mean of 50 (range 20-80) and a standard deviation of 10. Higher scores indicate more of the concept being measures where sometimes the concept is desirable (e.g., physical function) and sometimes this it is undesirable (e.g., fatigue). PROMIS instruments are scored using item-level calibrations based on response patterns by HealthMeasures Scoring Service.

Outcome measures

Outcome measures
Measure	AxoGuard® Nerve Cap n=30 Participants Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=35 Participants Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
The Change From Baseline of Patient Reported Outcome Measurement Information System (PROMIS®) Pain Behavior Scale Score at Month 12	-19.0 Pain Behavior Scale Score Interval -27.2 to -14.5	-17.1 Pain Behavior Scale Score Interval -28.2 to -4.6

SECONDARY outcome

Timeframe: 12 months

Population: Modified intent-to-treat (mITT) population, participants that completed at least one post-baseline assessment of efficacy. Analysis is based on the treatment as received.

The Foot Health Status Questionnaire (FHSQ) measures foot health related to quality of life based on responsiveness in overall foot health status in 4 subscale areas (foot function, foot health, footwear and foot pain). The FHSQ is comprised of 13 questions. The questionnaire is self-administered. Subscale ratings are summed and the FHSQ score is reported as 0 (poorest state of foot health) to 100 (optimal foot health) with higher scores reflecting better foot health and quality of life.

Outcome measures

Outcome measures
Measure	AxoGuard® Nerve Cap n=30 Participants Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=35 Participants Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
Change in Foot Health Status Questionnaire (FHSQ) General Foot Health Scale at 12 Post-operative Months Compared to Baseline.	36.7 FHSQ Score Interval 25.0 to 50.0	27.1 FHSQ Score Interval 0.0 to 50.0

SECONDARY outcome

Timeframe: 12 Months

Population: Modified intent-to-treat (mITT) population, participants that completed at least one post-baseline assessment of efficacy. Analysis is based on the treatment as received.

Change from pre-operative baseline in quantity of pain medication prescribed via morphine milligram equivalent (MME) at 12 months Opioid pain medications prescribed were converted to morphine milligram equivalent (MME) where such conversions are available to summarize pain medications by quantity of use.

Outcome measures

Outcome measures
Measure	AxoGuard® Nerve Cap n=30 Participants Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=35 Participants Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
As-Prescribed Opioid Medication	-0.89 Morphine Milligram Equivalent Interval -33.0 to 5.0	2.36 Morphine Milligram Equivalent Interval -20.0 to 50.0

SECONDARY outcome

Timeframe: 12 Months

Population: Analysis population derived from modified intent-to-treat (mITT) population participants that completed at least one post-baseline assessment of efficacy and reported medications in diary. Analysis was based on the treatment as received

Change from baseline in average daily quantity of pain medication taken via the Medication Quantification Scale (MQS) at 12 months. A daily pain medication log was provided to each participant to take home and complete each day and was collected at all visits. For opioid and non-opioid pain medications, the Medication Quantification Scale (MQS) Version III is a validated tool used to quantify the complexity and detriment of pain medication regimens. It calculates a single numeric value by combining medication detriment weights (ranging from 1.1 to 4.5) with dosage levels (scaled from 1 for subtherapeutic use to 4 for supratherapeutic use). A higher MQS score indicates greater potential medication detriment and/or dosage intensity. At 12 months, the study assessed changes from baseline in patients' average daily MQS scores.

Outcome measures

Outcome measures
Measure	AxoGuard® Nerve Cap n=24 Participants Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=26 Participants Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
As-Taken Medication	-1.70 MQS Units/Day Interval -20.0 to 3.0	-2.43 MQS Units/Day Interval -15.0 to 1.0

SECONDARY outcome

Timeframe: 12 Months

Population: Modified intent-to-treat (mITT) population, participants that completed at least one post-baseline assessment of efficacy. Analysis is based on the treatment as received.

Symptomatic neuroma recurrence was defined as: 1. VAS pain score higher at 12 months than baseline 2. Opioid medications (MME) higher at 12 months than baseline 3. Participant-reported pain \>1 (on scale of 0-10) at least once between 9 months and 12 months. Participants experiencing all three of the criteria were determined to have symptomatic neuroma recurrence.

Outcome measures

Outcome measures
Measure	AxoGuard® Nerve Cap n=30 Participants Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=35 Participants Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
Rate of Recurrence of Symptomatic Neuroma	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: This is the per-protocol (PP) population which includes all participants in the mITT population who have an endpoint for the analysis in question and have experienced no conditions that may confound study outcomes, such as sustaining a foot injury during study follow-up. Analysis is based on the treatment as received.

Total pain experienced by participants over the course of study follow-up was calculated from the area under the curve (AUC) of daily pain log scores reported on a 0-10 numerical rating scale. An AUC value was calculated for each participant and normalized to the total possible AUC based on the number of log entries reported for that participant. The AUC scores are reported as a proportion of the total possible AUC (on a scale of 0-1) for a participant and difference in mean treatment group values tested by a t-test.

Outcome measures

Outcome measures
Measure	AxoGuard® Nerve Cap n=36 Participants Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=37 Participants Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
Total Reported Pain From Baseline to 12 Months	0.104 Proportion of Area Under Pain*Time Curve Interval 0.019 to 0.161	0.187 Proportion of Area Under Pain*Time Curve Interval 0.028 to 0.233

SECONDARY outcome

Timeframe: 6 Months

Population: This is the safety population (SP) which includes all participants who had the study device inserted or underwent neurectomy. Treatment assignment is based on treatment as received.

The secondary safety endpoint will compare the rate of procedure- or device-related SAEs between treatment groups. The rate of serious adverse events for a given timepoint is given as the number of participants with one or more events up to that timepoint out of the population at risk.

Outcome measures

Outcome measures
Measure	AxoGuard® Nerve Cap n=41 Participants Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=43 Participants Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 6 Months	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: This is the safety population (SP) which includes all participants who had the study device inserted or underwent neurectomy. Analysis is based on treatment as received.

The secondary safety endpoint will compare the rate of procedure- or device-related AEs or UADEs between treatment groups. The rate of events or effects for a given timepoint is given as the number of participants with one or more events up to that timepoint out of the population at risk.

Outcome measures

Outcome measures
Measure	AxoGuard® Nerve Cap n=41 Participants Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=43 Participants Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 6 Months	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 9 Months

Population: This is the safety population (SP) which includes all participants who had the study device inserted or underwent neurectomy. Treatment assignment is based on treatment as received.

Outcome measures

Outcome measures
Measure	AxoGuard® Nerve Cap n=41 Participants Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=43 Participants Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 9 Months	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 9 Months

Population: This is the safety population (SP) which includes all participants who had the study device inserted or underwent neurectomy. Analysis is based on treatment as received.

Outcome measures

Outcome measures
Measure	AxoGuard® Nerve Cap n=41 Participants Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=43 Participants Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 9 Months	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: This is the safety population (SP) which includes all participants who had the study device inserted or underwent neurectomy. Analysis is based on treatment as received.

Outcome measures

Outcome measures
Measure	AxoGuard® Nerve Cap n=41 Participants Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=43 Participants Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 12 Months	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: This is the safety population (SP) which includes all participants who had the study device inserted or underwent neurectomy. Analysis is based on treatment as received.

Outcome measures

Outcome measures
Measure	AxoGuard® Nerve Cap n=41 Participants Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=43 Participants Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 12 Months	4 Participants	4 Participants

Adverse Events

AxoGuard® Nerve Cap

Serious events: 6 serious events

Other events: 16 other events

Deaths: 0 deaths

Standard Neurectomy

Serious events: 5 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AxoGuard® Nerve Cap n=41 participants at risk Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=43 participants at risk Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	2.4% 1/41 • 12 Months	0.00% 0/43 • 12 Months
General disorders IMPAIRED HEALING	2.4% 1/41 • 12 Months	0.00% 0/43 • 12 Months
Infections and infestations APPENDICITIS	2.4% 1/41 • 12 Months	0.00% 0/43 • 12 Months
Infections and infestations COVID-19 PNEUMONIA	2.4% 1/41 • 12 Months	0.00% 0/43 • 12 Months
Infections and infestations POSTOPERATIVE WOUND INFECTION	2.4% 1/41 • 12 Months	0.00% 0/43 • 12 Months
Injury, poisoning and procedural complications FOOT FRACTURE	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Injury, poisoning and procedural complications HIP FRACTURE	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROMA	2.4% 1/41 • 12 Months	0.00% 0/43 • 12 Months
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	2.4% 1/41 • 12 Months	0.00% 0/43 • 12 Months
Pregnancy, puerperium and perinatal conditions ABORTION SPONTANEOUS	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Skin and subcutaneous tissue disorders SKIN ULCER	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months

Other adverse events

Other adverse events
Measure	AxoGuard® Nerve Cap n=41 participants at risk Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.	Standard Neurectomy n=43 participants at risk Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Gastrointestinal disorders IMPAIRED GASTRIC EMPTYING	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
General disorders NODULE	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
General disorders OEDEMA	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
General disorders PERIPHERAL SWELLING	2.4% 1/41 • 12 Months	0.00% 0/43 • 12 Months
Infections and infestations CELLULITIS	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Infections and infestations COVID-19	2.4% 1/41 • 12 Months	2.3% 1/43 • 12 Months
Infections and infestations POSTOPERATIVE WOUND INFECTION	2.4% 1/41 • 12 Months	0.00% 0/43 • 12 Months
Infections and infestations SINUSITIS	2.4% 1/41 • 12 Months	0.00% 0/43 • 12 Months
Injury, poisoning and procedural complications FALL	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Injury, poisoning and procedural complications INCISION SITE ERYTHEMA	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Injury, poisoning and procedural complications INCISION SITE PAIN	2.4% 1/41 • 12 Months	2.3% 1/43 • 12 Months
Injury, poisoning and procedural complications INTENTIONAL MEDICAL DEVICE REMOVAL BY PATIENT	2.4% 1/41 • 12 Months	0.00% 0/43 • 12 Months
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Injury, poisoning and procedural complications STRESS FRACTURE	2.4% 1/41 • 12 Months	0.00% 0/43 • 12 Months
Injury, poisoning and procedural complications VACCINATION COMPLICATION	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Injury, poisoning and procedural complications WOUND DEHISCENCE	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Musculoskeletal and connective tissue disorders ARTHRITIS	2.4% 1/41 • 12 Months	0.00% 0/43 • 12 Months
Musculoskeletal and connective tissue disorders BURSAL FLUID ACCUMULATION	2.4% 1/41 • 12 Months	0.00% 0/43 • 12 Months
Musculoskeletal and connective tissue disorders METATARSALGIA	2.4% 1/41 • 12 Months	4.7% 2/43 • 12 Months
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL STIFFNESS	2.4% 1/41 • 12 Months	0.00% 0/43 • 12 Months
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	4.9% 2/41 • 12 Months	2.3% 1/43 • 12 Months
Musculoskeletal and connective tissue disorders PLANTAR FASCIITIS	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Musculoskeletal and connective tissue disorders TENDONITIS	2.4% 1/41 • 12 Months	2.3% 1/43 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	2.4% 1/41 • 12 Months	0.00% 0/43 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROMA	4.9% 2/41 • 12 Months	4.7% 2/43 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN PAPILLOMA	2.4% 1/41 • 12 Months	2.3% 1/43 • 12 Months
Nervous system disorders HYPOAESTHESIA	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Nervous system disorders NERVE COMPRESSION	0.00% 0/41 • 12 Months	9.3% 4/43 • 12 Months
Nervous system disorders NEURALGIA	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Nervous system disorders NEUROPATHY PERIPHERAL	2.4% 1/41 • 12 Months	2.3% 1/43 • 12 Months
Nervous system disorders PARAESTHESIA	2.4% 1/41 • 12 Months	0.00% 0/43 • 12 Months
Skin and subcutaneous tissue disorders EXCESSIVE GRANULATION TISSUE	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Skin and subcutaneous tissue disorders INGROWING NAIL	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Skin and subcutaneous tissue disorders SKIN ULCER	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Vascular disorders ESSENTIAL HYPERTENSION	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months
Vascular disorders HYPERTENSION	0.00% 0/41 • 12 Months	2.3% 1/43 • 12 Months

Additional Information

Stacy Arnold, VP of Product Development and Clinical Research

Axogen

Phone: 770-833-2570

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of at least sixty days prior to submission for publication for sponsor to review and comment. The Sponsor may extend the embargo for an additional 60 days to allow for the filing of a patent application or taking such measures Sponsor deems appropriate to establish and preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER