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Skin Substitute

Skin Substitutes for Diabetic Foot Ulcers

N/A
Recruiting
Research Sponsored by Encoll Corp
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus
The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus
Must not have
Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence
A subject has an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks
Awards & highlights

Summary

This trial aims to compare the effectiveness of standard of care treatment with Epifix or Grafix to Helicoll Advanced Skin Substitute in treating diabetic foot ulcers. The main goal is to see how much

Who is the study for?
This trial is for individuals with Wagner 1 diabetic foot ulcers. Participants should be suitable to receive standard care treatments like Epifix or Grafix, as well as a skin substitute called Helicoll. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that would exclude them from safely participating.
What is being tested?
The study compares the effectiveness of two treatments for diabetic foot ulcers: standard care (SOC) alone versus SOC combined with an FDA-cleared advanced skin substitute named Helicoll. The main goal is to see which treatment better reduces ulcer size over five weeks.
What are the potential side effects?
Potential side effects are not detailed in the provided information, but generally could include reactions at the treatment site such as redness, discomfort, or infection. As always with clinical trials, there may be unexpected side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with type 1 or type 2 diabetes.
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My foot ulcer is mostly below my ankle.
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I am 18 years old or older.
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My diabetic foot ulcer is between 1.0 and 10.0 cm2 after cleaning.
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My foot or ankle ulcer is deep but does not reach the bone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a bone infection or exposed bone confirmed by a doctor's exam or X-rays.
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I am currently taking antibiotics for an infection.
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My target ulcer is infected or the skin around it has cellulitis.
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I am currently taking medication to suppress my immune system or undergoing chemotherapy.
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I am not pregnant and do not plan to become pregnant in the next 6 months.
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I had a partial foot amputation that affects my ability to relieve pressure on my foot ulcer.
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I have a Charcot foot condition affecting my ulcer treatment.
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I am on dialysis for end-stage kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Percentage of wound area reduction
Secondary study objectives
Mean number of repeated applications
Proportion of complete closure
Time to achieve complete wound closure
Other study objectives
Appearance of the new skin by visual observation
Recurrence of the wound
Safety analysis for Treatment Emergent Adverse Events
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: SOC and Advanced Bioengineered Skin SubstituteExperimental Treatment1 Intervention
The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Helicoll® applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Dynaflex™ or equivalent).
Group II: SOC and Active ComparatorExperimental Treatment1 Intervention
The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Epifix® or Grafix® followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Dynaflex™ or equivalent).

Find a Location

Who is running the clinical trial?

Encoll CorpLead Sponsor
~16 spots leftby Sep 2025
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