Recruiting

Collagen-Silver vs. Standard Care

Sponsor:

Rosalind Franklin University of Medicine and Science

Code:

NCT00641433

Conditions

Ingrown Nail

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

oxidized regenerated cellulose collagen-silver

topical silver sulfadiazine cream

Study Details

Brief summary:

This study's purpose is to prospectively determine whether topical therapy with an oxidized regenerated cellulose collagen-silver compound is more effective than the current standard of topical antibiotic therapy for care following the removal of an ingrown toenail. Eighty adult patients with ingrown toenails will be recruited. Each patient will randomly be assigned to apply either topical silver sulfadiazine cream (standard antibiotic) or the novel collagen-silver compound to their nail bed daily, following removal of the ingrown portion of nail. Patients will return for follow up visits weekly, until healing has occurred or twelve weeks have passed. Healing will be defined as resolution of drainage and inflammatory changes surrounding the nail border.

Conditions

Ingrown Nail

Study ID

NCT00641433

Start date

Nov, 2005

Status verified date

Mar, 2008

Completion date

May, 2008

Anticipated

Primary completion date

May, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ingrown toenails will be defined as any incurvated nail border that digs into the skin of the nail fold and causes pain and discomfort

Exclusion Criteria:

  • Patients with immunocompromised states

  • chronic steroid use
  • diabetes mellitus
  • collagen vascular disease
  • HIV infection
  • Cellulitis proximal to the hallux interphalangeal joint or peripheral vascular disease will be excluded
  • We will define peripheral vascular disease as the absence of one or more pedal pulses or the presence of dystrophic changes to the integument

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: experimental

Subjects will daily dress their nail bed with oxidized regenerated cellulose collagen-silver, until healing occurs.

active comparator: Control

Topical silver sulfadiazine cream will be applied daily to the wound bed until healing has occured.

Interventions

oxidized regenerated cellulose collagen-silver

Wound dressed daily with oxidized regenerated cellulose collagen-silver matrix.

topical silver sulfadiazine cream

Cream will be applied to nailbed daily and dressed with a bandage until healing occurs.

Primary outcome measure

  • time to healing [ Time Frame: weekly ]

Central Contacts and Locations

Central contacts

David G Armstrong, DPM, PhD

847-578-8440david.armstrong@rosalindfranklin.edu

Locations

Scholl Foot and Ankle Center

Recruiting

North Chicago, Illinois, United States, 60064

Contacts

Ryan T Crews, MS

847-578-8437ryan.crews@rosalindfranklin.edu

Principal Investigator:

David Armstrong, DPM, PhD

Preofessional Education and Research Institutue

Recruiting

Roanoke, Virginia, United States, 24016

Contacts

Charles Zelen, DPM

540-725-5027cmzelen@periedu.com

Principal Investigator:

Charles Zelen, DPM

More Information

Sponsor

Rosalind Franklin University of Medicine and Science

Last update posted

Mar 24, 2008

Last verified

Mar, 2008

Keywords

  • chemocautery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rosalind Franklin University of Medicine and Science on 2008-03-24.