Title Clinical Protocol for Diabetic Foot Ulcer Grade 1&2 Wound

Care Management using (a) Botrem Restoractiv

Encapsulating Body Wash (b) Botrem Restoractiv INTENSIVE
intricate care wash. Normal Saline is used as control group

Allergy Disclaimer: Product contains 99% natural

ingredients. Refer to label information for ingredients
sensitivity risk BEFORE USE

Purpose To assess and qualify Botrem Restoractiv wash USE in

expediting wound healing process
Duration 90 days
Wound Assessment Integrated into procedure Yes No
Subject Experts Dr.Khairul Anwar
Total Number of sample 60 patients
Group consultant Head of Orthopedic Department Hospital
TuankuFauziah,Kangar, Perlis, Malaysia
Date of commencement June 2019
Date of completion of the September 2019
Clinical study

Botrem Wash (a) + Tap Normal Saline

Water
Outcome

Conclusion

Coordinator of the Study, Approved by,

……………………………………. ………………………………………
 Final Report
Title Clinical Protocol for Diabetic Foot Ulcer Grade 1&2 Wound
Care Management using (a) Botrem Restoractiv
Encapsulating Body Wash (b) Botrem Restoractiv INTENSIVE
intricate care wash. Normal Saline is used as control group

Allergy Disclaimer: Product contains 99% natural

ingredients. Refer to label information for ingredients
sensitivity risk BEFORE USE

Purpose To assess and qualify Botrem Restoractiv wash USE in

expediting wound healing process
Duration 90 days
Wound Assessment Integrated into procedure Yes No
Subject Experts Dr.Khairul Anuar
Total Number of sample 60 patients
Group consultant Head of Orthopedic Department Hospital
TuankuFauziah,Kangar, Perlis, Malaysia
Date of commencement June 2019
Date of completion of the September 2019
Clinical study

Botrem Wash (b) + Tap Normal Saline

Water
Outcome

Conclusion

Coordinator of study, Approved by,

.............................................. .............................................
Clinical Protocol for Diabetic Foot Ulcer Grade 1&2 Wound Care
Management using Botrem Wash(a) & (b) with Normal Saline as
control group

Introduction

The aim of this document is to provide the appropriate management strategy for optimum
wound healing, patient comfort and cost effectiveness in line with best practice/evidence.

All wounds must be assessed and reassessed by a competent registered health care
professional who will undertake a comprehensive assessment of the wound (site, size,
surface, grade and appearance, exudate type and volume, state of surrounding skin and
level of wound pain)

Target Group

60 patients with Diabetic Foot Ulcer using Wagner Classification Grades 1 & 2

Total Duration of Clinical Study

90 Days

Frequency of Dressing

15 patients Grade 1 DFU will require twice weekly Dressing with Botrem Body wash +
Tap water as an adjunct treatment

15 patients Grade 2 DFU will require 3 times weekly Dressing with Botrem Intricate Body
wash + Tap water as adjunct treatment

15 patients Grade 1 DFU will require twice weekly Dressing with Normal saline as an
adjunct treatment

15 patients Grade 2 DFU will require 3 times weekly Dressing with Normal saline as an
adjunct treatment
Tap Water

Any fears regarding bacterial contamination of tap water appear to be unfounded (Angeras
and Bradbard, 1992). Studies have shown no increased risk of infection if sutured wounds
are washed with soap and water (Noe and Keller, 1988) or when the patient showers
(Chrintz et al,1989).

Microbiologists suggest running the tap water for a few minutes to flush out potential
bacteria accumulations prior to use as a precautionary measure. Beam (2006) in an
extensive review found tap water to be equally effective to saline when used as a cleansing
agent.

INITIAL AND ONGOING WOUND ASSESSMENT

Assessment should include information from different sources. It should bring together
general and specific information on the patient, the skin, the circulation and the wound
itself.

Holistic assessment of the patient is an essential part of the wound care process.

WOUND BED PREPARATION

The aim of wound bed preparation (WBP),is a process to create an optimal wound-healing
environment. The core precept of WBP is to focus on both the wound and the patientas a
whole. This approach will frequently require a multidisciplinary and structured approach to
caredelivery.

Necrotic tissue

Wound containing dead tissue:

 It may appear hard, dry andblack.

 Dead connective tissue may appeargrey.
 Eschar with time may soften by autolysis and bacterialliquefaction.
 The presence of dead tissue in wounds delayshealing.
 Necrotic tissue in Ischaemic leg ulcers should be left dry – moist wound healing is
not promoted with this wound aetiology

Slough

Slough is formed by an accumulation of dead cells in the wound exudate. It is light yellow
in colour and must not be confused with infected tissue orpus.

Granulation tissue

Healthy red tissue occurs during the proliferative phase of wound healing. Fibroblasts
migrate to the wound to produce collagen fibres. The tissue is well vascularised and bleeds
easily.
Epithelial tissue

The process by which the wound surface is covered by new epithelium, this begins when
the wound has filled with granulation tissue. The tissue is pink, almost white, and occurs
on top of healthy granulation tissue.

WOUND MEASUREMENT

Wound measurement is vital to monitor the healing process of a wound. The wound should
be measured at its greatest length and breadth using a sterile measuring ruler in the
dressing packs. The depth of the wound is measured using a sterile probe with the
patient’s head being the guide reference at 12 O’clock position.
Wound assessment for Diabetic foot ulcer to record on first contact and then weekly
Wound bed

Size

Sensation

Temperature

% of Healing