A Multi-Centre Study

A MULTI-CENTRE STUDY INTO THE CLINICAL APPLICATIONS OF THE DENTRON BIOGUN IN CHIROPODIAL/PODIATRIC PRACTICE (Reprinted from the Dentron Biogun Technical Construction File)

Jonathan Copus, Dentron Limited

AIM OF THE STUDY

Between 1991 and 1998, Dentron Limited sponsored research into the effectiveness of the Biogun in killing micro-organisms in vitro, and a two-year clinical study into the efficacy of the device in treating dental root-caries in vivo. Much of this work was supported by the Department of Trade and Industry through a succession of SMART awards. During that time the Biogun was in regular clinical use by chiropodists/podiatrists throughout the UK and elsewhere, and in June, 1992 the Company began compiling data returned by chiropodists/podiatrists using the Biogun in clinical practice. The latest results included in this study were received in August, 2001 and collated into a multi-centre study of the application of the Biogun in chiropodial/podiatric practice. The aim of this study is to ascertain the effectiveness of the device over a wide range of clinical conditions, practitioners and types of patient and practice, in circumstances which reflect real-life usage.

PRACTITIONERS

The practitioners involved were all qualified chiropodists/podiatrists and members either of the Institute of Chiropody and Podiatry (MInstChP) or of the School of Surgical Chiropody (MSSCh).

PRINCIPLES AND METHODS

Because realism was one of the primary aims of the study, practitioners were asked to follow the manufacturer’s current instructions for using the device as closely as possible, but were otherwise left free to exercise their professional judgment about the appropriate course of treatment in each case. What this approach lacked in tight control of parameters was amply compensated for in its ability to reflect actual practice by working practitioners in the field.

SELECTION OF PATIENTS AND CONDITIONS

The study involved a total of 25 centres, 203 patients and 30 conditions. Further details are given in Tables 1 and 2.

Practitioners were given a free hand in selecting suitable patients and conditions for treatment. The criteria for inclusion in the study were therefore that the patient had presented at a participating chiropody/podiatry surgery or requested domiciliary treatment, had been adjudged suitable for treatment with the Biogun by the practitioner, and had in fact been so treated. A further criterion for inclusion was that the records submitted contained all the required data in a reliable form. The only criterion for exclusion from the study was lack of complete or reliable data. The demographic profile of patients is given in Table 22.

RESULTS

The results of the study are collated in Tables 3-21. They show that the Biogun was considered an effective treatment in cases of verruca pedis and other warts, fungal nail infections, leg ulcers, tinea pedis, onycholysis, inflamed skin cracks, septic heloma, streptococcal infection of the foot, bedsores, onychomycosis, corns, hallux valgus plantar bursa, inflamed onychocryptosis, acne, psoriasis, eczema, ringworm rash and inflamed bunion.

DISCUSSION

The main value of this study lies in its breadth. While it does not profess to be a full-scale clinical trial, it does demonstrate that the Biogun as used in clinical chiropodial/podiatric practice is an effective instrument in treating a range of conditions. When these results are taken in conjunction with other, more tightly controlled clinical studies (such as the three on verruca pedis by Stephens and Vernon and the two-year dental clinical trial) and the in vitro results on 41 micro-organisms (all noted elsewhere in the Biogun Technical Construction File), they support the conclusion that the Biogun is an effective surface microbicide on a variety of sites in the human body.

TABLE 1: CENTRES USED IN THE STUDY

Table 1has been removed in the interests of confidentiality.

TABLE 2: PATIENTS BY CENTRE

Table 2 has been broken down into separate tables for each condition.

Table 3: VERRUCA PEDIS

CENTRE REF	PATIENT INITIALS	SEX	AGE	DIAGNOSIS	PATIENT REF
A	BM	M	30	VP x 2	A004
A	JV	F	6	VP x 2	A005
B	DN	M	34	VP x 26	B001
B	JB	M	51	VP	B002
B	ME	F	33	VP x 5	B003
C	MG	F	14	Mosaic VP + hand warts x 2	C001
D	JB	M	17	VP x 5	D001
E	.	M	6	VP	E001
E	.	F	6	VP	E002
F	D	M	30	VP x 2	F001
F	DS	M	16	VP Hallux	F002
F	DC	M	8	VP	F003
F	KB	F	20	VP x 2	F004
G	MS	F	8	VP	G002
I	MB	F	45	VP	I002
I	M	F	12	VP x 2	I005
K	EF	F	70	VP x 2 & warts x2	K002
K	P	F	74	VP	K003
K	EM	F	11	VP	K004
K	RM	M	58	VP	K005
L	DB	M	10	VP	L001
L	KE	F	9	VP	L003
L	JG	M	7	VP + tinea pedis	L004
M	.	M	35	VP	M001
M	.	F	59	VP	M002
M	.	F	17	VP	M003
M	-	F	40	VP	M004
M	.	F	26	VP	M005
M	.	M	24	VP	M006
M	.	M	44	VP	M007
M	.	M	10	VP	M008
M	.	M	40	VP	M009
M	.	M	6	VP	M010
M	.	F	39	VP	M011
M	.	F	12	VP	M012
M	.	M	45	VP	M013
M	.	M	42	VP	M014
M	.	F	45	VP	M015
M	.	M	6	VP	M016
M	.	M	72	VP	M017
M	.	F	20	VP	M018
M	.	M	44	VP	M019
M	.	F	23	VP	M020
M	.	F	18	VP	M021
M	.	F	18	VP	M022
M	.	F	6	VP	M023
M	.	F	27	VP	M024
M	.	F	18	VP	M025
M	.	F	43	VP	M026
M	.	M	9	VP	M027
M	.	F	30	VP	M028
M	.	M	31	VP	M029
M	.	F	5	VP	M030
M	.	M	36	VP	M031
M	.	F	44	VP	M032
O	CP	F	4	VP	O001
P	LE	F	30	VP	P001
P	SC	F	23	VP	P002
P	Mrs H	F	40	VP	P003
P	Miss D	F	25	VP x 11	P005
Q	GC	F	12	VP x 2	Q001
Q	SO	M	30	VP	Q002
R	.	M	36	Multiple VP	R004
S	PH	F	31	VP	S008
S	AS	M	17	VP x 2	S012
T	NC	F	28	VP x 4	T002
T	BP	M	63	VP	T003
T	MJH	F	69	VP	T004
U	DB	F	18	Multiple VP both feet	U001
U	AN	F	21	VP	U002
U	JE	F	28	VP	U003
U	ND	F	29	VP x 5	U004
V	AT	M	11	VP x 3	V005
W	MS	F	40	VP	W004
W	JL	F	5	VP	W014
W	EC	F	7	VP x 2	W016
W	NB	F	36	VP x 2	W019
W	EC	F	4	VP	W020
W	LC	F	6	VP x 2	W021
W	CC	M	19	VP x 2	W022
W	RF	F	11	VP	W023
W	PF	M	47	VP	W026
W	AmcT	F	57	VP	W027
W	KG	M	29	VP	W036
W	MG	F	20	VP	W037
W	PH	M	49	VP	W043
W	TD	M	73	VP	W049
W	SD	F	6	VP x 2	W050
W	PD	F	65	VP x 2	W051
X	SB	F	6	VP	X005
X	CS	M	69	VP	X006
X	CN	M	53	VP	X007
Y	JBG	M	20	VP x 2	Y001
Y	PMcN	F	56	VP x 2	Y006
Y	JT	M	77	VP	Y008

Data analysis

Participating centre references	A B C D E F G I K L M O P Q R S T U V W X Y
No. of participating centres	22
No. of patients	94
No. of instances of condition	162 + multiples
Mean treatment duration per instance (minutes)	13.51
Mean no. of treatment sessions per patient	3.31
Mean duration of course (days)	42.98
Percentage of instances cured	100
No. of cases cured without medication	0

Table 4: ONYCHOMYCOSIS

CENTRE REF	PATIENT INITIALS	SEX	AGE	DIAGNOSIS	PATIENT REF
A	MM	F	69	Fungal nail infection x 10	A001
A	NP	M	39	Fungal nail infection x 10	A002
A	DT	M	74	Fungal nail infection x 10	A003
H	ST	F	45	Onychomycosis	H003
H	SC	F	58	Onychomycosis	H004
H	AEN	F	60	Onychomycosis	H005
N	EW	F	40	Fungus infection great toenail x 2	N002
O	EH	F	61	Nail fungus	O005
U	PD	M	60	Onychomycosis & tinea pedis both feet	U005
W	FJ	M	73	Onychomycosis	W005
W	BI	F	62	Onychomycosis	W007
W	KH	F	57	Onychomycosis	W008
W	MH	F	37	Onychomycosis	W010
W	CH	F	67	Onychomycosis	W011
W	JH	F	53	Onychomycosis	W012
W	AM	F	62	Onychomycosis	W013
W	PF7	M	47	Onychomycosis	W025
W	AF	F	57	Onychomycosis	W028
W	PF	F	57	Onychomycosis	W029
W	VF	F	41	Onychomycosis	W030
W	MF	F	59	Onychomycosis	W032
W	LF	F	53	Onychomycosis	W034
W	JF	M	76	Onychomycosis	W035
W	NC	F	44	Onychomycosis	W038
W	UC	F	52	Onychomycosis	W040
W	MH	F	37	Onychomycosis	W041
W	AH	F	64	Onychomycosis	W042
W	FH	F	51	Onychomycosis	W044
W	JH	F	71	Onychomycosis	W045
W	CH	F	44	Onychomycosis	W046
W	JH	M	46	Onychomycosis	W048
W	EH	F	65	Onychomycosis	W053
X	SB	M	82	Onychomycosis	X002

Data analysis

Participating centre references	A H N O U W X
No. of participating centres	7
No. of patients	32
No. of instances of condition	61
Mean treatment duration per instance (minutes)	34.43
Mean no. of treatment sessions per patient	4.66
Mean duration of course (days)	81.34
Percentage of instances cured	95.01
No. of cases cured without medication	58

Table 5: TINEA PEDIS

CENTRE REF	PATIENT INITIALS	SEX	AGE	DIAGNOSIS	PATIENT REF
L	AC	M	32	Tinea pedis	L002
L	JG	M	7	Tinea pedis	L004
N	JM	F	30	Severe athletes foot x 2	N001
O	CP	M	21	severe tinea pedis	O002
O	MP	M	45	Tinea pedis	O003
O	SH	M	32	severe athletes foot	O006
O	MG	F	60	Tinea pedis	O008
P	Mr H	M	60	Tinea pedis	P004
R	.	M	2	athletes foot	R002
R	.	M	67	athletes foot	R003
S	ML	M	28	Tinea pedis	S002
S	NB	F	62	VP & Tinea pedis	S006
S	TM	F	34	Tinea pedis	S011
U	PD	M	60	Onychomycosis & tinea pedis both feet	U005
W	CJ	F	52	Tinea pedis	W006
W	JC	M	33	Tinea pedis + onychomycosis	W015
W	NB	F	36	Tinea pedis	W018
W	LF	F	53	Tinea pedis	W033
W	JH	M	25	Tinea pedis + mycotic rash	W047
X	CB	F	72	Tinea pedis	X003
X	HB	M	80	Tinea pedis	X004

Data analysis

Participating centre references	L N O P R S U W X
No. of participating centres	10
No. of patients	21
No. of instances of condition	22
Mean treatment duration per instance (minutes)	21
Mean no. of treatment sessions per patient	2.19
Mean duration of course (days)	32.1
Percentage of instances cured