EDX110 for Foot Ulcer

Recruiting at 3 trial locations

Overseen By Christina Mastandrea

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ConvaTec Inc.

Must not be taking: Systemic corticosteroids, Chemoradiation

Disqualifiers: Severe infections, Active Charcot deformity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

298 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new dressing system, EDX110, can heal diabetic foot ulcers more effectively than usual care alone. Participants will receive either the EDX110 dressing with standard treatment or just the standard treatment. It suits those with a diabetic foot ulcer present for at least a month that isn't healing well. The ulcer should be on the foot, not too deep, and show mild signs of infection. Participants must have diabetes but should not have severe infections or foot deformities that could affect healing. As an unphased trial, this study offers a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids over 10mg/kg/day or undergoing chemotherapy or radiation therapy, you may not be eligible to participate.

What prior data suggests that the EDX110 dressing system is safe for treating diabetic foot ulcers?

Research has shown that EDX110 is generally safe for treating foot ulcers. One study found that EDX110 had a good safety record, with fewer serious ulcer-related issues compared to the usual treatment. Among the serious problems reported, only a few were linked to EDX110, indicating that patients generally handle it well. Another study also found that EDX110 was well-tolerated, with some unwanted effects occurring, though most were not serious. Overall, EDX110 appears to be a safe option for helping foot ulcers heal. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for diabetic foot ulcers, which typically involves cleaning, debridement, and protective dressings, EDX110 introduces a new type of wound dressing designed to enhance healing. Researchers are excited about EDX110 because it potentially offers a more effective way to support wound recovery, possibly working by promoting better moisture balance and providing an optimal environment for healing. This innovative approach could lead to faster recovery times and improved outcomes for patients with foot ulcers, making it a promising advancement in ulcer treatment.

What evidence suggests that EDX110 might be an effective treatment for foot ulcers?

Research has shown that EDX110 may help heal diabetic foot ulcers. In this trial, participants will divide into two groups: one will receive EDX110 with Standard of Care (SOC), while the other will receive only the Standard of Care. One study showed that 63% of people using EDX110 improved, compared to 30% with regular treatment after 24 weeks. Another study found a 45% healing rate with EDX110, while standard care had a 23% rate. EDX110 also reduced wound size faster, achieving results in 4 weeks that took the regular treatment group 12 weeks. These findings suggest that EDX110 could greatly improve healing for people with diabetic foot ulcers. ^{1 2 3 4 6}

Who Is on the Research Team?

Christina M Mastandrea, MS

Principal Investigator

ConvaTec Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with type 1 or type 2 diabetes who have non-healing diabetic foot ulcers (DFUs) that haven't improved in at least 4 weeks but are less than 24 months old. The ulcer must be a full-thickness wound, not too large, and may show mild signs of infection. Participants need to commit to the study's procedures and follow-ups.

Inclusion Criteria

I am 18 or older and agree to follow all study requirements.

My foot ulcer has not started healing after 4 weeks.

I have a deep wound classified as Wagner Grade 1.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either EDX110 with standard of care or standard of care alone for diabetic foot ulcers

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Extension

Participants continue to be monitored for wound closure and other outcomes

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EDX110

Trial Overview

The EDX110 Randomized Control Trial tests if adding the EDX110 dressing system to standard care improves healing of DFUs compared to standard care alone. This prospective study randomly assigns participants equally into two groups, one receiving the new treatment plus standard care and the other just standard care.

How Is the Trial Designed?

Group I: EDX110 with Standard of Care (SOC) Active Control 1 Intervention

Diabetic Foot Ulcer (DFU) DFU treatment with EDX110 wound dressing and SOC

Group II: Standard of Care (SOC) Active Control 1 Intervention

Diabetic Foot Ulcer (DFU) DFU treatment with using only traditional Standard of Care (SOC)

Who Is Running the Clinical Trial?

ConvaTec Inc.

Lead Sponsor

Trials

52

Recruited

5,900+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40632068/

Cost-effectiveness of a nitric oxide-generating medical ...

Results: There was a 63% improvement in healing by 24 weeks in the EDX110 group compared with standard care (49% versus 30%, respectively). This ...

2.

diabetesonthenet.com

diabetesonthenet.com/diabetic-foot-journal/topical-nitric-oxide-in-diabetic-foot-ulcers-unlocking-the-power-of-biological-molecules/

Topical nitric oxide in diabetic foot ulcers

Here, EDX110 showed a marked trend toward better outcomes: a 45% healing rate versus 23% with standard care. While this difference did not reach ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6330625/

Reflections on the effects of nitric oxide produced by a new ...

Wound size reduction in the EDX110 group at 4 weeks was similar to that achieved by the control group at 12 weeks. Participants with an ulcer sized ≥1 cm2 and ...

4.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/wrr.12630

Multicenter, randomized controlled, observer‐blinded study ...

Furthermore, within the EDX110 group itself, there was also a significant improvement in PAR of ulcers of ≤ 6 months duration compared to that ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06640985

EDX110 - Efficacy and Safety in the Management of Hard ...

Prospective, single-center, non-blinded, non-randomized, post-market study to determine the efficacy of EDX110 dressing system in diabetic foot ulcers (DFUs) ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29617058/

Multicenter, Randomized Controlled, Observer-Blinded ...

EDX110 was well tolerated. Thirty serious adverse events were reported (12 in the EDX110 group, of which 4 were related to the ulcer; 18 in the control group, ...