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Enzymatic Debriding Agent

Using Santyl on Diabetic Foot Ulcers

Phase 4
Waitlist Available
Research Sponsored by Healthpoint
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 weeks
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Pivotal Trial
Drug Has Already Been Approved

Summary

Subjects enrolled in this study will either use Santyl daily or follow standard care procedures for up to 6 weeks for their diabetic foot wound. After 6 weeks of treatment, the subjects will continue into the follow-up phase for an additional 6 weeks. Study doctors will look at the wound in the office each week (up to 12 weeks) to see if the wound is healing. Depending on a number of factors at each office visit, the study doctors may also use a procedure called sharp debridement to remove dead skin from the wound. This study will test the hypothesis that daily treatment of diabetic foot wounds with Santyl will result in more rapid healing, healthier wounds, and fewer required sharp debridements over the study period than for diabetic foot wounds treated in other ways.

Eligible Conditions
  • Foot Ulcer
  • Diabetic Foot Wounds

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Percent Change in Wound Area

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Group I: SantylActive Control1 Intervention
2mm Santyl applied once daily.
Group II: ControlActive Control1 Intervention
Standard Care

Find a Location

Who is running the clinical trial?

HealthpointLead Sponsor
35 Previous Clinical Trials
3,077 Total Patients Enrolled
8 Trials studying Foot Ulcer
533 Patients Enrolled for Foot Ulcer
Herbert B Slade, MDStudy ChairHealthpoint
26 Previous Clinical Trials
1,936 Total Patients Enrolled
5 Trials studying Foot Ulcer
217 Patients Enrolled for Foot Ulcer
~4 spots leftby Dec 2025