Next Science Wound Gel Efficacy in Chronic Wound Versus Standard of Care


About this study

This is a 3 to 4 months, single site, prospective randomized clinical study of patients diagnosed with a chronic wound. The primary objective is to assess changes in healing rate, by measuring differences in wound area when treating chronic wounds with the Next Science Wound Gel compared to the Triple Antibiotic Ointment Neosporin (Standard of Care, SOC).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female 18 years or older
  • Presence of full-thickness wound for more than one month (i.e. chronic)
  • Ulcer must be greater than 1 centimeter in area to enable biofilm sampling
  • NOT a candidate for vascular reconstructive surgery to restore blood flow to the wound
  • Willing to comply with all study procedures and be available for the duration of the study
  • Provide signed and dated informed consent

Exclusion Criteria:

  • Subjects unable to provide signed and dated informed consent
  • Male or female less than 18 years old
  • Presence of a full-thickness wound for less than one month
  • A candidate for vascular reconstructive surgery to restore blood flow to the wound
  • Subjects with bleeding dyscrasia or with medical conditions that would make a bleeding complication likely
  • Subjects who's wound is less than 1 cm precluding adequate wound biofilm sampling
  • Subject with known allergic reaction to the study products

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Albert Hakaim, M.D.

Closed for enrollment

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