Topics

Prevention of Infection Using a Topical Gentamicin-Collagen Sponge in Diabetic Patients With An Uninfected Foot Ulcer

2014-07-24 14:18:05 | BioPortfolio

Summary

The purpose of this study is to determine the safety and efficacy of the Collatamp G topical gentamicin collagen sponge (gentamicin sponge) combined with standard of care (daily wound care, off-loading, diabetic control and debridement by a physician or podiatrist), compared with placebo sponge combined with standard of care, in preventing infection of diabetic lower extremity skin ulcers.

Description

Infected skin ulcers with diabetes can be very debilitating because they are difficult to heal. Diabetic ulcers are responsible for frequent health care visits, and are a major predictor of amputation. Diabetic ulcers can be caused by a patient's inability to sense pain or warmth as well as peripheral vascular disease, which causes diminished blood flow to the foot. Early aggressive treatment is necessary to prevent infection and ultimately prevent the need for amputation.

Gentamicin is an antibiotic that is effective in treating certain kinds of infection. Collagen is a protein that is found in all mammals. The gentamicin-collagen sponge is a thin flat sponge made out of collagen that comes from cow tendons and containing gentamicin. When applied to an open ulcer, the collagen breaks down and the gentamicin is released into the ulcer, but very little is absorbed into the blood stream. The high levels of gentamicin in the open infected ulcer may help treat the infection.

In this study, all subjects will be given the necessary supplies and taught how to take care their foot ulcer. Subjects will be randomly assigned to receive either the gentamicin-collagen sponge or a plain collagen sponge. The sponge will be applied into the ulcer twice a week during the treatment period.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Conditions

Diabetic Foot Ulcer

Intervention

gentamicin-collagen sponge, placebo collagen sponge

Location

Chesapeake Foot and Ankle Center
Pasadena
Maryland
United States
21122

Status

Terminated

Source

Innocoll Technologies

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:18:05-0400

Clinical Trials [2200 Associated Clinical Trials listed on BioPortfolio]

Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot Ulcer

The purpose of this study is to determine whether the gentamicin-collagen sponge (Collatamp G topical) when combined with standard of daily wound care is safe and effective in treating mil...

The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers

The purpose of this study is to determine whether the gentamicin-collagen sponge (Collatamp G topical) when combined with standard daily wound care and an oral antibiotic (levofloxacin) is...

A Study of an Antibiotic Implant in General Surgical Subjects at Higher Risk for Surgical Wound Infection

The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective for preventing surgical wound infections in patients undergoing colorectal surgery.

Efficacy and Safety of A Collagen Bupivacaine Implant in Patients After Gastrointestinal Surgery

The purpose of this study is to determine whether the CollaRx Bupivacaine Implant (bupivacaine sponge) is safe and effective in reducing the amount of narcotic pain medication needed to co...

Slow-release Tb4 Collagen and Chitosan Porous Sponge Scaffolds Skin Substitute Treatment is Difficult to Heal Wounds

Evaluation of slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes the effectiveness of clinical trials for the treatment of difficult to heal wounds and securit...

PubMed Articles [4302 Associated PubMed Articles listed on BioPortfolio]

In vitro efficacy of gentamicin released from collagen sponge in eradication of bacterial biofilm preformed on hydroxyapatite surface.

Biofilm-related infections of bones pose a significant therapeutic issue. In this article we present in vitro results of the efficacy of gentamicin released from a collagen sponge carrier against Stap...

Collagen dressing in the treatment of diabetic foot ulcer: A prospective, randomized, placebo-controlled, single-center study.

Because collagen is fundamental to wound healing and skin formation, collagen-containing dressing materials might be beneficial in treating diabetic foot ulcers (DFU), but supporting evidence is neede...

Physicochemical, antioxidant properties of giant croaker (Nibea japonica) swim bladders collagen and wound healing evaluation.

Acid-solubilized collagen (ASC) and pepsin-solubilized collagen (PSC) were obtained from Nibea japonica swim bladders. The denaturation temperature (Td) of ASC and PSC was approximately 33.8 °C. So...

Collagen Sponge Scaffolds Containing Growth Factors for the Functional Regeneration of Tracheal Epithelium.

Tracheal epithelia have barrier and mucociliary clearance functions that prevent invasion of extraneous particles and infectious materials. Hence, following tracheal reconstructions, functional and mo...

Ultralow anterior resection with implantation of gentamicin-collagen sponge and no defunctioning stoma: anastomotic leakage and local cancer relapse.

Background Anterior resection with total mesorectal excision (TME) of ultralow rectal cancer may result in the increased risk of the anastomotic leakage (AL). The aim of this study was to evaluate the...

Medical and Biotech [MESH] Definitions

Sterile, gelatin-base surgical sponge applied topically as an adjunct to hemostasis when the control of bleeding by conventional procedures is ineffective to reduce capillary ooze or is impractical. (From AMA Drug Evaluations Annual, 1994, p797)

A fibrillar collagen found widely distributed as a minor component in tissues that contain COLLAGEN TYPE I and COLLAGEN TYPE III. It is a heterotrimeric molecule composed of alpha1(V), alpha2(V) and alpha3(V) subunits. Several forms of collagen type V exist depending upon the composition of the subunits that form the trimer.

A fibril-associated collagen usually found crosslinked to the surface of COLLAGEN TYPE II fibrils. It is a heterotrimer containing alpha1(IX), alpha2(IX) and alpha3(IX) subunits.

A fibrillar collagen found primarily in interstitial CARTILAGE. Collagen type XI is heterotrimer containing alpha1(XI), alpha2(XI) and alpha3(XI) subunits.

A non-fibrillar collagen that forms a network of MICROFIBRILS within the EXTRACELLULAR MATRIX of CONNECTIVE TISSUE. The alpha subunits of collagen type VI assemble into antiparallel, overlapping dimers which then align to form tetramers.

More From BioPortfolio on "Prevention of Infection Using a Topical Gentamicin-Collagen Sponge in Diabetic Patients With An Uninfected Foot Ulcer"

Quick Search

Relevant Topics

Wound management
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...

Diabetes
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...

Infectious-diseases
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...


Searches Linking to this Trial